Hyderabad
INR 10.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.
Hyderabad, Mumbai (All Areas)
INR 27.5 - 42.5 Lacs P.A.
Work from Office
Full Time
Educational Qualification- Post-graduate degree in Pharmacology or other Medical speciality/ Graduate degree in Medicine Minimum work experience - 6-12 years of relevant experience as Medical Advisor with a minimum of 3 years of experience in GASTRO Therapy Area. Must have a prior experience of NCE/NBE launches in GASTRO Therapy area Skills & attributes Technical Skills • Basic knowledge of pharmaceutical industry, drug discovery, research & development, commercialization, promotion, and applicable policies, procedures, regulations, and guidelines • Knowledge of “pharmaceutical medicine” including clinical pharmacology, medical and paramedical sciences, medicine and medical statistics and relevant Therapeutic Area/Products • Expertise in clinical trial design and methodology, and understanding of interfaces, and conduct Behavioural Skills • Communication skills, both written and verbal (including medical writing and presentation skills) • Analytical skills and reasoning, and sound medical judgment/decision making • Interpersonal skills, internal & external networking and the ability to impact and influence. Job Summary We are looking for experienced and dynamic T eam Lead in Medical Affair team for Gastro TA to actively contribute to the organization/business by taking people managerial responsibility and being responsible for the scientific, technical and ethical soundness of all policies, statements and endeavours. He/she will need to provide high quality and timely service in the areas of product commercialization/promotional support, interactions with healthcare professionals, continuing medical education, clinical research, sales force training, medical information, and performance/people management, and business support in the areas of new product development, regulatory affairs, quality standards, and information technology; alliance management may be included as applicable. Roles & Responsibilities • You will be responsible to provide tactical and strategic inputs, and business/technical expertise, to Product Management towards ethical promotion of assigned products, in the operational areas listed • You will be responsible for providing strategic inputs for marketing and brand plans, overseeing the design and execution of medical-marketing programs, and facilitating interactions with healthcare professionals. Additionally, you will initiate, review, and approve promotional and educational materials while ensuring compliance with relevant SOPs, regulations, and industry codes. • You will be responsible for developing, reviewing, and approving protocol documents and supporting materials for various clinical projects. Additionally, you will collaborate with Global Medical Affairs and Clinical Development, organize training sessions for project teams, and provide medical support for safety reporting and ongoing local studies. Furthermore, you will contribute to the planning and execution of Investigational New Drug Applications (NDAs). • You will be responsible to provide useful, timely, accurate, and balanced medical information to internal (sales staff) and external customers. • You will be responsible for training the Sales Force on basic sciences/assigned products and pre-launch and launch training for new products. • You will assist the New Product Planning team in preparing business cases and pre-commercialization programs for global products, development of local formulations and line extensions. Additionally, you will provide support in market research, stakeholder mapping, and early access programs. You will also collaborate with various departments to evaluate commercial opportunities, including licensing, acquisitions, and co-promotion. • You will be responsible for providing medical and product expertise in the registration of new products/indications, as well as defending marketed products to various stakeholders. You will also oversee the writing and review of labelling documents and provide medical support for the processing of adverse event reports, adhering to relevant SOPs and practices. • You will be responsible to develop and share expertise in identified medical and/or scientific therapeutic area, including but not limited to disease areas, markets, products (DRL products and key competitors) and services. • You will be responsible to develop and share expertise in a specific medical/scientific subject, including protocol design, development, and training, Pharma co economics, Outcomes Research, Health Technology Assessment, New Product Evaluation, Disease Management Programs, Intellectual Property Protection and Patents, and Medical Information • You will be one-point Medical Affairs contact for Customer Relationship Management and operational liaison in the various functional domain. • You will be responsible for fostering a culture of learning and development and managing the Medical Affairs staff, providing training, guidance, and support across various functional domains, ensuring adherence to company values and behaviours, and. • You will be responsible to support cluster Head Medical Affairs in budgeting, provisioning and expense control. Interested candidates can apply who is handling a team and working in gastro segment
Hyderabad
INR 10.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Job Summary We are seeking a dynamic and experienced Formulation Scientist in Topical division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Topical formulations (Creams, Ointment, Gels, Sprays and Foams) including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD). You will be responsible to support in scale-up to pilot/plant scales for topicals. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technologytransfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization,processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documentsfor drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materialsand ensure development studies are performed related to regulatory and internal system requirements. you will be responsible on preparation of assessments for impurities including Nitrosamine impurities and should be well versed with guidelines of India market, Russia market and US market requirements. Qualification Educational qualification: Masters in Pharmaceutical Technology/Pharmaceutics Minimum work experience: Approx. 5 years of experience in pharmaceutical company topical products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in Topical dosage forms Experience in areas of product development for Generic topical dosage forms Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Hyderabad
INR 5.0 - 10.0 Lacs P.A.
Work from Office
Full Time
Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Hyderabad
INR 35.0 - 50.0 Lacs P.A.
Work from Office
Full Time
Job Summary We are looking for Team Member-Medical information & Customer Support for ensuring efficient processing of quality complaints and adverse events. You will collaborate with various internal stakeholders, including the quality, PV teams, sales, marketing, and legal teams, to address customer concerns and ensure compliance with standard operating procedures (SOPs) and regulatory guidelines. Your responsibilities will include handling customer complaints, providing accurate medical information, coordinating adverse event reporting, and maintaining effective communication with cross-functional teams. Roles & Responsibilities Customer Services Cell (CSC) Ensuring Efficient Quality Complaint and Adverse Event Processing Collection of Complaint samples, original bill copy from customers through marketing team, sending them to QA and collection of filled CIOMS and sending them to PV teams. Ensuring the free flow of complaints with regard to their Logging and Closing through CSC mail/telephone. Follow-up with the Customers, Marketing, Pharmacovigilance and Quality Assurance teams for better processing of complaints. Monthly Reconciliation of AEs with the (GPVC) Pharmacovigilance Team. Answering Product related Queries of the Customers via Customer Services Mail Box on daily basis Medical Information (Info-Jini) services Addressing scientific Power point presentation requests received from HCPs through the sales team and Medico-Marketing Team Responding to the Scientific Query Requests from the external customers sent through the sales team and Medico-Marketing Team Managing clinical queries related to GGI portfolio products by providing scientific evidence based literature to sales or marketing team Administrative work - to ensure proper compilation and extracting of the data in Info-Jini. Preparation of log-sheets, Monthly report sheets, outsourcing, archiving, maintenance of Journals & library/database. Toll-Free services – Effectively handling calls from various external stakeholders on product queries and reporting quality/PV complaints. Maintain logs of the calls and appropriately report to the internal teams through customer services cell. Cross functional interaction for closure of issues Assist in handling customer queries, complaints, and adverse event reporting. Support interactions with both internal and external stakeholders to facilitate resolution. Assist in providing essential information for medical inquiries from doctors, coordinating with various stakeholders to ensure accurate and timely responses. Audits Assist in maintaining documentation to ensure readiness for internal and external audits. Support the implementation and adherence to corrective and preventive action plans (CAPA) as directed. Qualification Educational qualification: M. Pharm, Pharm D. or Phd will be value addition. Minimum work experience: 3-4 years of experience in customer service-oriented roles, Regulatory Affairs/PV/Medical Information/ Medical Writing. Managerial experience/Training customer services/call centers will be added advantage. Skills & attributes: Technical Skills • Proven experience in customer support or client service representation. Sound scientific knowledge • Customer-oriented mindset with the ability to adapt and respond effectively to internal and external stakeholders. • Proficiency in Microsoft Word, Excel, and PowerPoint. Behavioural skills • Strong written and verbal communication skills. Excellent interpersonal & communication skills to effectively interact with a broad range of audience Ability to interact and handle challenging internal and external stakeholders Driving quality standards by taking everyone along Integrity driven decision making skills Strong multitasking skills with keen attention to detail. Effective time management and organizational skills to manage multiple tasks efficiently. Self-awareness and adaptability Result oriented and performance driven Strong sense of empathy in addressing customer calls Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Hyderabad
INR 10.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Job Summary We are seeking an experienced Lead in analytical development who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for stability testing, test method development/validation, method transfers and other related requests from Research & Development (R&D) or formulation development. Roles & Responsibilities • You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. • You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners • You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization • You need to co-ordinate and follow up with external labs including training of their staff. • You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. • You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. • You will have to participate in handling and resolution of laboratory non-conformances with related documentation • You will be responsible for analytical methods and process compliance as per quality assurance requirement. Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills • Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies • Efficient in MS Office, Word/Excel/PowerPoint functionalities • Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. • Ability to understand analytical methods defined by global and local bodies • Ability to resolve analytical issue associated with different product matrix. • Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. • Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate • Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills • Systematic approach and strategic thinking • Possess excellent interpersonal skills, communication, coordination, and time-management skills • Ability to independently handle teams • Excellent oral/written communication and articulation skills • Passion for people development • Ability to prioritize work and change focus quickly • Ability to delegate effectively
Hyderabad
INR 5.5 - 15.5 Lacs P.A.
Work from Office
Full Time
Job Description Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualifications Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams.
Hyderabad, Navi Mumbai
INR 5.0 - 8.0 Lacs P.A.
Work from Office
Full Time
Scientific Business Officer Position: Scientific Business Officer Incumbent: O1-1A Supervisor and Position (L+1): Regional Sales Manager Superior and Position (L+2): Sales Manager PURPOSE To generate prescription through science based communication within assigned territory by implementing defined strategies. Also ensure product availability at chemist stores to prevent Rx substitution. OPERATING NETWORK The role holder works in active collaboration with PMT ,Distribution and services the following customers Doctors, Stockists, Chemists ,Purchase Officers in hospitals . MINIMUM REQUIREMENTS Required Education: Science Graduate/ B Pharm. MBA will be desirable. Minimum Experience Minimum 3.5 Years Experience in niche therapies Knowledge: Basic Anatomy To understand science related to our products Basics of Marketing & Sales To understand the marketing strategy and appreciate the brand communication prepared by Marketing Computer Knowledge (MS Office, Internet)To use various IT Applications (Palm, MS Office etc.) in day to day operations of field sales. Product Knowledge Of the assigned therapy to have a confident communication with the doctors. Key Skills Required: Particulars:-1Communication:- In chamber communication. Positive body language in front of the customers. 2Influencing :- selling the perception created by the PMT to the doctors. Convincing the chemist/ Stockist to keep the stocks. 3High Energy Level :- cover his/ her territory and achieve targets of coverage of all levels of customers. i.e. doctors, Stockist, chemist etc. 4Learnability :- A person inculcate the product knowledge and marketing strategy related to products every quarter and quickly convert it to Rx in the doctor's chamber. 5Decision Making :- A CRM Investments decisions to be taken.. 6Comprehensions :- A person to comprehend articles/ journals related to molecules and engage the doctor in a dialogue. 7Perseverance :- A Person To face the high rate of rejections associated with this job and keeps the spirits high. 8Analytical Skills :- a person to analyze the performance.
Guwahati, Mumbai (All Areas)
INR 6.0 - 16.0 Lacs P.A.
Work from Office
Full Time
KAM MARKET ACCESS Job Summary: The ideal candidate will have a strong background in public channel sales, particularly within the pharmaceutical industry, and a proven track record of selling innovative products in super specialities such as oncology, rheumatology, gastroenterology (GI), and orthopaedics (ortho). This role requires excellent relationship management skills with public health stakeholders and key accounts in the public channel sales sector. Key Responsibilities: Achieve sales targets and drive revenue growth for innovative pharmaceutical products in the public channel. Develop and maintain strong relationships with public health stakeholders, including government institutions and key accounts. Ensure the inclusion and availability of new products in the public health sector. Identify and capitalize on market opportunities to expand product reach and market share. Collaborate with cross-functional teams to develop and implement market access strategies. Monitor and analyse market trends, competitor activities, and regulatory changes to inform business decisions. Provide regular reports and updates on sales performance, market conditions, and key account activities. Engage with senior stakeholders such as Health Secretaries, Managing Directors of National Health Mission (MD NHM), Directors of Health Services (DHS), and Directors of Medical Education and Research (DMER) to advocate for product inclusion and address any concerns. Organize and participate in meetings, presentations, and discussions with senior public health officials to promote the benefits and efficacy of innovative products. Build and sustain long-term partnerships with key decision-makers in the public health sector to facilitate smooth product adoption and integration. Understand the Program Implementation Plan (PIP) of national health programs at the state level and align it with the company's objectives to drive product inclusion and availability. Work closely with state health departments to ensure the successful implementation of PIP and support the achievement of public health goals. Qualifications: Bachelor's degree in Life Sciences, Business, or a related field. Advanced degree (MBA, MSc) preferred. 5-8 years of experience in pharma public channel sales or government institutional business. Proven experience in selling innovative products in super specialities such as oncology, rheumatology, GI, and ortho. Strong network and relationships with public health stakeholders and key accounts. Excellent communication, negotiation, and interpersonal skills. Ability to work independently and as part of a team. Strong analytical and problem-solving abilities.
Visakhapatnam
INR 15.0 - 30.0 Lacs P.A.
Work from Office
Full Time
Role & responsibilities • You will be responsible for serving as a TPM Facilitator & Coordinator, collaborating closely with the Site Leadership team on COE (Center of Excellence) ways of working to achieve Zero Defects, Zero Breakdowns, and Zero Minor Stoppages while enhancing operator capability. • Your role involves working with operations, maintenance, and quality teams on the shop floor to drive AWW/COE, OEE (Overall Equipment Efficiency) improvements, and conduct Root Cause Analysis. • To achieve improvements, you will drive initiatives such as Kaizens, OPL (One Point Lesson), and Kaizen Blitz, along with implementing Lean Daily Management at Tier-2 & Tier-1. • You will be responsible for conducting periodic OE reviews with the site head, and preparing MIS (Management Information System) reports while maintaining effective communication with the Site and Central teams. • Additionally, you will conduct training sessions for team members on Work Better (WB), TPM Tools in Plant. • Your responsibilities also include dealing with external agencies such as consultants and vendors. Preferred candidate profile • Good knowledge of TPM methodologies, with mandatory hands-on experience in Jishu-Hozen (JH), Planned Maintenance (PM), Kobetsu-Kaizen (KK), and Quality Maintenance (QM) pillars. • Experience with Six Sigma Green Belt (Six Sigma GB) would be an added advantage. • Foundational Financial Acumen, including the ability to understand COGs (Cost of Goods) and perfuming cost benefit analysis. • Experience as a TPM Facilitator & Coordinator, and working knowledge of OE practices and Lean principles. • Experience in applying Lean Daily Management at Tier-2 & Tier-1, Kaizens, One-Point Lessons (OPL), and Kaizen Blitz. • Experience in driving Root Cause Analysis for operational issues. • Ability in training team members on Workshops and TPM Tools in a plant setting.
Hyderabad
INR 35.0 - 50.0 Lacs P.A.
Work from Office
Full Time
The PV Scientist is primarily responsible for the conduct of benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation, review and submission of aggregate reports; signal detection; support of benefit-risk evaluation efforts; generation of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification and tracking of risk minimization measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities. Other activities relevant to the medical assessment responsibilities can also include: Query management; coordination with internal and external stakeholders for assigned medical assessment activities, and quality review of deliverables. All of the above are conducted in accordance with regulatory requirements and internal DRL standards. Main Responsibilities: Signal management: Conduct signal management activities for assigned products, performing initial review of signal alerts, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. This may include interaction with the LifeSphere Signal Management System and/or review of outputs generated from the system. Aggregate Reports and RMPs: Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar. Maintain and harmonize global trackers for all aggregate reports across the regions Preparation of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, ACOs. Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor and by internal resources. Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements Prepare RMPs and contribute to REMS activities as required Contribute to the implementation and tracking of additional risk minimization measures in collaboration with PV physicians, local affiliates and third party partners Prepare Health Hazard Evaluations and other ad hoc safety reports as requested Conduct benefit-risk evaluations under the supervision of PV physicians Clinical & Regulatory Activities: Provide safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review reconciliation, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings. Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required Labeling document review: under the supervision of PV physicians, provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV –related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required Raise deviations to PV processes where identified Participate in development of CAPA and take ownership of CAPA completion where assigned Participate in regular, scheduled meetings with PV team/service provider/third parties as required Initiate or support the development and revision of PV Medical Assessment SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV Medical Assessment Activities. Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training Perform other ad hoc, PV related activities as requested by head medical assessment Relationship Management Working within PV team and cross-functionally Interactions with vendors/service providers for PV activities Process Improvement / Standardization Participate in process improvement initiatives, as applicable Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing Desired Skills & Competencies Good working knowledge of PV regulations including FDA, EU & local requirements. Strong data analysis and report writing skills Excellent teamwork and interpersonal skills Excellent time management and organizational skills Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc. Qualification M. Pharm (Pharmacology) or equivalent with 3 to 7 years of experience in pharmacovigilance with experience in writing and reviewing PV Medical Writing Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com
Baddi
INR 500.0 - 1000.0 Lacs P.A.
Work from Office
Full Time
Responsibilities Roles and Responsibility of a Safety officer Under Rule - 61(A) of HP Factories act. Implementation of Safety trainings as per calendar schedule Safety management plan implementation Safety Incidents investigation with incident investigation team Conducting Safety observations & interactions & Contractor Safety Field Audit rounds as per the schedule Organize safety committee meetings and Implementation PPE stock management (Indenting PPE) Review and approval of Change request note, User requirement specifications &Major maintenance requests as per the safety compliance. Drive Safety promotional activities Monitor the safety performance of engineering department and ensure that safety score improves (tracking scheduled meeting, activities etc) Safety SPOC for GDC ware houses - ensure that identified safety systems are implemented at GDC ware houses (CSM, SOI, etc.) Monitor the implementation of LOTO progress across the plant and ensure 100% compliance to LOTO Track the implementation status of all the other Engineering standards (CSM, Working at height, Confined space, Machine safety etc.) Control over portable tools & Ladder in the plant through gate entry and inspection mechanism Conduct contract employees L-1 & L-2 training completion as per SOP and track L-3 training progress Carryout Risk assessment for all the activities in the engineering section& suggest engineering controls for the identified gaps Tracking of the compliance status of work permit system on daily basis and generate a report Impart Technical safety training for the Employees/ contract workmen Developing safe operating procedures for all the activities in the engineering section and integrating them in the existing SOPs Prepare for various GMP & Customer audits from the SH&E side Ensure that all the lifting tools, Tackles, Safety valves are inspected as per the statutory requirements and records are maintained along with addressing of deviations if any. Ensure that all the safety valves are inspected at least once in a year and in good condition Conducting Mock drills one in 2 months - Yearly plan, conducting the drill, publishing the report and tracing CAPA Publishing overdue CAPA report for all the zones of the plant once in a fortnight Maintaining Fire alarm & Public addressing system Maintaining Fire hydrant system in its desired state - Daily checks, weekly checks, Monthly report generation etc. Fire extinguishers monthly & by monthly inspection, maintaining the extinguishers as per the SOP Coordinating fire fighters activities and addressing the issues identified by the fire fighters Solvent line inspection once in 2 months. Administrative role in smooth functioning of OHC - Injury management, Compliance to SA requirement, compliance to SA 8000 requirement. Mandatory Skills 1.0 Roles and Responsibility of a Safety officer Under Rule - 61(A) of Telangana Factories act Years Of Experience : 15 to 20 Years Education/Qualification : B Tech requirement, compliance to SA 8000 requirement. Expected Skills : 1.3 Safety Incidents investigation with incident investigation team,1.4 Conducting Safety observations & interactions & Contractor Safety Field Audit rounds as per the schedule 1.5 Organize safety committee meetings and Implementation Mandatory Skills : 1.0 Roles and Responsibility of a Safety officer Under Rule - 61(A) of Telangana Factories act Qualification M.Tech, M.SC, B. Tech Additional Information
Hyderabad
INR 10.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information
Mumbai
INR 35.0 - 50.0 Lacs P.A.
Work from Office
Full Time
Job Summary We are seeking an experienced and dynamic Brand Manager to ensure successful brand growth and the launch of innovative market-driven products for gathering market insights from Key Opinion Leaders (KOLs), developing and executing new product launch plans, conducting effective sales force training, and implementing market research strategies for brand performance enhancement. Collaborating with the SCM team for product availability and maintaining strong relationships with KOLs. Roles & Responsibilities • You will be responsible for generating new product ideas from Key Opinion Leaders (KOL) interactions, prioritizing these ideas, preparing business cases, analyzing market and competitor data, and handling creative aspects like branding. The aim is to ensure the timely launch of products that address unmet market needs. • You will be responsible for marketing planning by preparing product launch materials, coordinating launch meetings, training the sales force, and tracking initial product performance for the first 12 months to ensure effective product marketing. • You will be responsible for brand performance review by gathering market insights, identifying key issues, and implementing action plans to maintain optimal brand performance, including conducting market research for brand positioning correction. • You will be responsible for interacting with Key Opinion Leader (KOLs), conducting fieldwork to gather insights, updating KOLs on product value, and collating product evidence and clinical reports to build strong relationships and drive growth. • You will be responsible for Supply Chain Management (SCM) by tracking product quantities and supply, sharing new product plan quantities with the SCM team, and promptly addressing product shortages or excess to ensure product availability in the market. • You will be responsible for meeting with Regional Sales Managers (RSMs) to collect feedback, gather campaign feedback, and develop region-specific strategies to incorporate regional needs into the product plan and improve performance. Qualification Educational qualification- Science/Pharma/Medical Graduate preferably with MBA in Marketing Minimum work experience- 4-5 years of experience in Sales & Marketing Skills & attributes Technical Skills: • Understanding of Pharmaceutical industry; ability to interpret market data; gain marketing insights from various resources • Basic understanding of anatomy and physiology. • Ability to analyze market trends, competitor activities, and customer needs within the generics market. • Strong problem-solving skills to address regulatory challenges, market access issues, and product-related obstacles. Behavioral Skills: • Strong collaborator and excellent communication. • Good at building and leveraging relationship. • Adaptability and change management skills. • Creative and good Analytical thinker. Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Baddi
INR 500.0 - 1000.0 Lacs P.A.
Work from Office
Full Time
Job summary We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines. Roles & Responsibilities • Your responsibilities encompass testing assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis. • Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy. • You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits. • Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification. • You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques. Qualification Educational qualification: An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology Minimum work experience : 2 years Skills & attributes: Technical Skills • Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends. • Hands-on experience in High-Performance Liquid Chromatography (HPLC) techniques, including Size Exclusion, Reverse Phase, Ion Exchange chromatography, and Peptide mapping analysis, especially within the context of Analytics. • Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics. • Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP). • Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques. • Basic knowledge and hands-on exposure to Microbiology techniques, particularly relevant for individuals working in Microbiology Labs. • Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioanalytics (BA) Labs. Behavioural skills • Prioritizes effective communication and demonstrates a performance-oriented mind-set. • Effective verbal and written communication skills. • Performance-oriented approach, consistently striving for high standards. • Demonstrates flexibility in working shifts and a clear understanding of team dynamics. Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Hyderabad
INR 35.0 - 50.0 Lacs P.A.
Work from Office
Full Time
Job Summary We are seeking an experienced analytical development scientist who can plan analytical projects based on priorities and established timelines, provide timely analytical delivery for test method development/validation, method transfers, stability testing and other related requests from Nutraceutical product development. Roles & Responsibilities You will have to prepare and review of technical documents e.g. stability reports, method transfer and method validation protocol and reports, etc. You need to manage communication with stakeholders such as project leaders, product development, analytical teams and other business partners You need to facilitate productivity improvement through proper planning of analytical activities and resource optimization You need to co-ordinate and follow up with external labs including training of their staff. You will need to review of analytical data for accuracy, compliance to quality requirements and completeness e.g. lab notebooks, raw data, system entries, etc. You will have to review of technical documents such as analytical reports, method transfer /method validation protocols, reports, etc. You will have to participate in handling and resolution of laboratory non-conformances with related documentation You will be responsible for analytical methods and process compliance as per quality assurance requirement in including QMS. You will be responsible to establish shelf life of products by statistical methods and preparation of shelf life assessment documents. Manage lab always in compliant status and responsible for calibration and maintenance of equipments. Qualification Education Qualification - MSc Chemistry, MSc Food Science, B.Tech/M. Tech in Dairy Technology Minimum experience required -10 – 15 years of experience in analytical development department and must have worked on nutritional product portfolio. Skill Attributes Technical Skills Technical expertise related to chemistry, analytical techniques, stability study assessment and advanced research technologies Efficient in MS Office, Word/Excel/PowerPoint functionalities Ability to interact with external labs and 3rd party manufacturing site labs to support product development team. Ability to understand analytical methods defined by global and local bodies and prepares internal STP for different products. Ability to resolve analytical issue associated with different product matrix. Good understanding and working experience of analytical equipments like HPLC, LC-MS/MS, ICP-OES, ICP-MS, Mozonnier, Kjeldahl etc. Good knowledge and working experience in proximate analysis and quantification of Vitamins and Minerals in nutrition products with complex matrix. Can handle equipment individually and train other scientists and third party staff. Should be familiar with analytical methods defined by national and international bodies like Association of Official Agricultural Chemists (AOAC), Bureau of Indian Standards (BIS) etc. Excellent knowledge of Good Laboratory Practices (GLP), Quality systems, Standard Operating Procedures, latest regulatory trends, and Global regulations as appropriate Data review, interpretation of analytical data and accurate documentation of laboratory investigations. Behavioural Skills Systematic approach and strategic thinking Possess excellent interpersonal skills, communication, coordination, and time-management skills Ability to independently handle teams and experiments Excellent oral/written communication and articulation skills Ability to prioritize work and change focus quickly Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Hyderabad
INR 35.0 - 50.0 Lacs P.A.
Work from Office
Full Time
Coordinate with internal (i.e. Execution team, API-RA, Plant, SCM, CPPK etc.) as well as external counterparts (i.e. external API manufacturing and testing sites etc.) Trigger request for all the administrative documents like foreign CPP, Indian CoPP/FSC/WHO GMP from respective CFT's and list down the open issues, also provide the document request to plant. To co-ordinate and understand the on-going review status of the product in the lead markets and update the API Plus project simultaneously demanding its review stage and tentative approval timeline. Draft deficiency responses, co-ordinate with CFTs, track the action items and review the documents for deficiency response. Display ability for timely response to deficiencies Demonstrate the ability to communicate the essential requirements to CFTs. Provide all the launch sheets and tech-packs, to facilitate timely launch of products. Support commercial team with tender related documents. Archive the submissions, responses, and other data in product folder. Qualification M Pharm/Masters in science Experience : 10 -15+ years Handing the Customer Audits and MoH Audits at our Manufacturing sites. Technical Skills Understanding of Good Manufacturing practice/Quality Systems. Understanding of product development, manufacturing processes, Intellectual Property and quality. Experience in handling various dosage forms like solid orals and sterile dosage forms. Sound knowledge of International Council for Harmonisation (ICH) / European Medicines Agency (EMA) guidelines on submission requirements and basic understanding of global regulatory affairs including United States Food Drug Approval requirements. Behavioral Skills Excellent communication and interpersonal skills. Efficient Leader and a good collaborator. Effective planning and high level of performance orientation. Strong analytical and problem-solving abilities. Additional Information
Hyderabad
INR 10.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Monthly book closure on operating expense of business unit by analysing the actual accounted during the month and ensuring the accounting of appropriate provisions. Preparation of monthly operating expense trends analysis and presenting the business reasons for variances. Ensuring accounting accuracy of transactions holistically through underlying agreement reviews and support for certain payments. Raising debit notes and credit notes for inter-company transactions and ensuring accounting of transactions in both the entities, enabling the timely payments for inter-co outstandings, periodic reconciliation of balances. Preparation of detailed schedules for balance sheet captions, maintain hygiene and follow up and closure on long outstanding balances. Ensuring to comply with accounting policies, accounting manual and documentation standards, internal controls and SOX. Support for statutory and internal audits. Enable information automation, process simplification, handling special projects and assignments. Qualification MBA (or) semi-qualified CA/CMA with 4 to 6 of Years experience. Positive attitude and enthusiastic, accounting acumen, Presentation Skills, MS Excel (advanced), SAP working knowledge, Eye of detail, Good Communication skills. Additional Information Dr Reddys Bachupally Campus, Hyderabad, Telangana.
Hyderabad
INR 35.0 - 50.0 Lacs P.A.
Work from Office
Full Time
Job Summary We are looking for a Product Manager to develop, implement, and maintain long-term strategies for high-potential products in our current and future portfolio, aiming to maximize market share and profitability through strategic planning and execution. Roles & Responsibilities • You will be responsible for conducting an in-depth evaluation of the competitive landscape and identifying opportunities for the organization. This involves defining key success factors and requirements necessary for a successful product launch and owning the product strategy document. • You will define the commercial strategy for the product early on, including market access strategy and plan, and creating marketing materials. • Your role includes supporting countries in generating local market access, if required, and executing market research activities to evaluate market potential and strategies. • You will also identify and mitigate potential hurdles, threats, and risks, both at the front end and back end. • You will ensure cross-functional alignment on forecasts, product volume capacity requirements, and launch preparation, including recommendations for long-term product-specific capacity investments. • You will be accountable for the product's profit and loss (P&L), including profitability calculation reflecting product-specific sales and marketing costs and other investments before and after handing over to markets. • Your role includes defining and monitoring the life cycle management strategy with development teams and optimizing product allocation for products under supply constraints. • Your responsibilities extend to portfolio optimization and rationalization, involving commercial growth strategies, portfolio rationalization, and conducting in-depth costing analysis and improvement strategies to enhance overall performance. Qualification Educational qualification: B.Pharm./M.Pharm. and MBA Minimum work experience: 12-15 years of experience Skills & attributes: Technical Skills • Proficiency in managing and coordinating development projects from initiation to completion, including setting project goals, timelines, resource allocation, and risk management. • Experience in preparing for new product launches, including market analysis, competitor research, launch strategy development, and coordination with various departments to ensure successful market entry. • Expertise in overseeing the entire lifecycle of commercial products, including product planning, pricing, positioning, and promotion to maximize profitability and market share. • Experience in understanding market research, including market trends, customer preferences, and competitor activities for strategic decision-making. • Knowledge of market access strategies and marketing tactics to ensure products are accessible to target markets and effectively promoted to healthcare providers, payers, and patients. • Proficiency in sales and marketing strategies, including customer relationship management, lead generation, sales forecasting, promotional campaigns, and sales performance analysis. Behavioural skills • Ability to collaborate effectively with cross-functional teams, including R&D, marketing, sales, finance, and regulatory affairs, to achieve project objectives and deliver results. • Strong leadership and communication skills, with the ability to influence stakeholders at all levels. • Critical thinking and problem-solving skills for investigations and process optimization. • Strong strategic thinking and decision-making skills. • Attention to detail and ability to multitask in a fast-paced environment. Additional Information
Hyderabad
INR 10.0 - 20.0 Lacs P.A.
Work from Office
Full Time
Job Summary: We are looking for a skilled, enthusiastic and experienced Scientist to join our Immunogenicity team. This role supports the nonclinical development of complex generics and differentiated products from strategy and development to product approval, across all verticals and global markets. Roles & Responsibilities Immunogenicity Risk Assessment: Responsible to develop and implement strategies for in-vitro immunogenicity risk assessments, including literature surveillance, execution, and evaluation during development and submission stages. Assay Development and Execution: Responsible to independently design, optimize, and perform in-vitro cell-based assays, immunological assays, immune cell profiling, and biomarker analysis for API, complex generics, and differentiated products. Cytokine and T-cell Assays: Responsible to establish and validate cytokine release immunogenicity assays and T-cell proliferation assays using PBMCs to support product development. Study Coordination and Data Analysis: Responsible to plan, execute, and coordinate nonclinical in-vitro studies, manage test articles with cross-functional teams, conduct experiments, analyze data, perform statistical evaluation, and compile reports for internal review. Regulatory and Scientific Research: Responsible to continuously gather and analyze peer-reviewed literature, regulatory guidelines, and scientific reports related to immunogenicity, contributing to team discussions and decision-making. Documentation and Compliance: Responsible to prepare and maintain SOPs, STPs, study reports, and incident records, ensuring adherence to QMS and organizational safety standards. Cross-functional Collaboration: Responsible to engage with internal teams and external stakeholders to support immunogenicity assessments and ensure alignment with project goals and regulatory requirements. Qualification Educational qualification: PhD in Biological Sciences/ M.Sc/ M.Tech in Biological Sciences/Pharmacology Minimum work experience: 3 years in Pharma Industry with M.SC/M.Tech or fresh PhD graduate Technical Skills: C ell Culture Handling: Proficiency in maintaining primary and established cell lines, handling PBMCs, and sterile culture techniques. Immunoassays: Expertise in ELISA, multiplex cytokine analysis, and in-vitro immunogenicity assays for immune response evaluation. Flow Cytometry (FACS): Skilled in immune cell phenotyping, fluorescence-based sorting, and multi-color panel design. MACS-Based Cell Isolation: Experience in magnetic bead separation for immune cell enrichment and functional assays is an added advantage. Data Analysis: Strong statistical analysis skills using GraphPad Prism and Excel for result interpretation, visualization, and reporting. Behavioural Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Ability to multi-task, prioritize and deliver effectively under stringent timelines Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
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