176 Anda Jobs - Page 2

Specialized expertise in Inhaler Products including Metered Dose Inhalers (MDI) and Dry Powder Inhalers (DPI). Method development, validation, and forced degradation studies specific to inhalation dosage forms. Execution and support of technology transfer for analytical methods related to MDI/DPI. Ensure compliance with Quality Assurance systems and applicable regulatory guidelines (ICH, FDA, EMA). Lead analytical activities for ANDA and NDA projects for respiratory products. Coordinate with cross-functional teams for project planning, documentation , and timely regulatory submissions. Review and preparation of analytical method validation protocols, reports, and supporting documentation for regulatory filings. Active involvement in OOS/OOT investigations, troubleshooting, and CAPA implementation.

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical accuracy. Support regulatory query responses related to product development and manufacturing in collaboration with relevant departments. Lead technology transfer of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets. Provide technical and regulatory support for submissions including NDA, ANDA, and 505(b)(2) applications. Troubleshoot formulation-related issues during manufacturing to ensure smooth and compliant commercial production.

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP for Oil & Gas Joint Venture Accounting Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that solutions are effectively implemented across multiple teams, while maintaining a focus on quality and efficiency in application delivery. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure alignment with strategic goals. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP for Oil & Gas Joint Venture Accounting.- Strong understanding of financial accounting principles and practices.- Experience with application lifecycle management.- Ability to analyze and optimize business processes.- Familiarity with integration techniques for various applications. Additional Information:- The candidate should have minimum 12 years of experience in SAP for Oil & Gas Joint Venture Accounting.- This position is based at our Hyderabad office.- A 15 years full time education is required. Qualification 15 years full time education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Document Management Systems (DMS) Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure project milestones are met, facilitating discussions to address challenges, and guiding your team through the development process. You will also engage in strategic planning sessions to align project goals with organizational objectives, ensuring that the applications developed meet the needs of stakeholders and users alike. Your role will require you to balance technical oversight with team management, fostering an environment of innovation and collaboration. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of application features. Professional & Technical Skills: - Must To Have Skills: Proficiency in Lorenz docuBridge or other regulatory submission & publishing management system.- Experience in supporting Publishing applications- Experience in working in Lorenz docuBridge- Must have functional & technical skill in regulatory publishing systems.- Strong domain knowledge & understanding of application design principles and best practices.- Ability to troubleshoot and resolve technical issues effectively.- Familiarity with integration of Lorenz docuBridge with other enterprise systems. Additional Information:- The candidate should have minimum 5 years of experience in Lorenz docuBridge or similar document systesms.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Reviewing submission related documents including Inactive Ingredient Evaluation, Q1/Q2, Product Development Report, Quality Plan, Product Manual, Trade dress, Specifications, Master Packaging Card and Validation Protocols/Reports etc. DMF Review for ANDA submissions. Outlining requirements for labelling, storage and packaging for FDA submission. Compilation of ANDA sections of US market for sterile dosage form. Review of manufacturing related documents such as BMR, BPR and Stability study Protocols /Reports etc. To draft response and timely submission for regulatory deficiencies. To coordinate with cross-functional teams for regulatory requirements. Keeping up to date with regulatory guidelines

: Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs Method Validation Protocol knowledge. Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products. Initiate Change controls as necessary for: Method and specification revisions and stability Protocol Modules preparation for Drug substance and Drug product. Batch Analysis - 32S/32P Reference Standards - 32S/32P Characterization of Impurities - 32S/32P Justification of Specification - 32S/32P Facility Templates Stability Summary Reports for ACC, CRT & RT 5313 Reports (Dissolution Comparative test) QOS & Stability Overview - 32S/32P (If ANDA) To prepare vendor qualification report based on the performance of material at test. To prepare justification reports towards reduction of tests in Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing. Preparation/Review of SOPs Required Skills: Analytical method Validation documentation : Advanced Laboratory Instrumentation Knowledge : Intermediate Data Integrity (ALCOA+ principles) : Advanced CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) : Advanced Impurity Profiling & Justification : Intermediate Stability Profiling Knowledge : Advanced

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables. Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements. Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions. Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed. Participate in internal and external audits and inspections related to regulatory compliance. Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation Qualifications Bachelors degree in a science, pharmacy, or a related field; advanced degree (e.g., Masters, PhD) preferred. Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry. Skills Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment. Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams. Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.

•Direct the preparation and submission of regulatory agency applications, reports, or correspondence. •Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Required Candidate profile Experience in Regulatory Affairs function with experience in preparing DMF for US / EU / Japan / ROW market and handling their queries / deficiencies.

Original Application submission Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve outs based on patents and exclusivity claims Labeling Query responses/ REMS and Patent Amendments/ PNP Requests Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested Life Cycle Management Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change SLC notification from FDA Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS) Timely submission of REMS Review of revised artworks

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Prepare DMFs (Dossier Management Facility) for regulatory submissions. Ensure compliance with FDA regulations and guidelines throughout product lifecycle management. Collaborate with cross-functional teams to develop formulations that meet regulatory requirements. Provide expertise on drug regulatory affairs, including labeling, claims, and risk assessment. Desired Candidate Profile M.Pharma degree from a recognized institution. Minimum 15-24 years of experience in Regulatory Affairs - Formulations. Strong understanding of FDA regulations and guidelines. Excellent communication skills for effective collaboration with stakeholders.

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile and Allergy Therapy Products, and Generics Solid Dosage Formulations. Jubilant Generics (JGL) is a wholly - owned subsidiary of Jubilant Pharma which is subsidiary to Jubilant Pharmova Limited. Jubilant Generics have 2 manufacturing sited at Roorkee, Uttarakhand and Salisbury, Maryland, USA engaged in manufacturing of Tablets and Capsules. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. This business team focusses on B2B model for EU, Canada and emerging markets. Kindly refer www.jubilantpharmova.com for more information about organization. JOB RESPONSIBILITIES : ;;;;;;;;;;;;; Accountabilities;;;;;;;;;;;;;;;;;;;;;;;;;;; Scope of work US Drug Dossier Authoring, Reviewing and Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation and Submission Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan and complete regulatory filing activities Review and finalization of artwork/label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends eCTD publishing Coordination Interface with R and D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R and D/ADL against DMF/Dossier requirements Reporting and Maintenance Maintain regulatory files/database

Role & responsibilities Knowledge about countroller ,servo ,vacuum And Pneumatics System Of equipment Root Cause Analysis and Problem Solving knowledge about cpk And GRR Knowledge About Glue Dispensers Machines Like ANDA Asymtek and Camalot Machines

Job Summary As a Sr. Consultant specializing in Devices you will play a pivotal role in driving innovative solutions and strategies for our clients. With a hybrid work model and day shifts you will collaborate with cross-functional teams to enhance device-related processes and outcomes. Your expertise will contribute to the companys mission of delivering cutting-edge technology solutions that positively impact society. Responsibilities Lead the development and implementation of device strategies to optimize client outcomes and enhance operational efficiency. Oversee the analysis of device-related data to identify trends and opportunities for improvement. Provide expert guidance on device selection integration and lifecycle management to ensure alignment with client objectives. Collaborate with cross-functional teams to design and execute device-related projects that meet client needs and expectations. Develop and maintain strong relationships with clients to understand their device requirements and provide tailored solutions. Ensure compliance with industry standards and regulations in all device-related activities. Drive continuous improvement initiatives to enhance device performance and reliability. Conduct training sessions and workshops to educate clients and internal teams on device best practices. Monitor and report on the progress of device projects ensuring timely delivery and quality outcomes. Support the development of proposals and presentations for potential device-related projects. Evaluate emerging device technologies and trends to identify opportunities for innovation. Facilitate knowledge sharing and collaboration among team members to foster a culture of learning and growth. Utilize your domain expertise to contribute to the companys strategic goals and enhance its reputation in the device sector. Qualifications Possess a minimum of 8 years of experience in the devices domain demonstrating a strong track record of success. Exhibit excellent analytical skills to interpret complex device data and derive actionable insights. Demonstrate proficiency in device lifecycle management and integration strategies. Have a solid understanding of industry standards and regulatory requirements related to devices. Show exceptional communication skills to effectively convey technical information to diverse audiences. Display strong problem-solving abilities to address device-related challenges and implement effective solutions.

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other medical specialists, such as neurologists, audiologist, and speech therapists, to provide comprehensive patient care.Maintaining accurate and complete patient records, including medical history, exam results, diagnostic images, and treatment plans.Participating in continuing education programs and conferences to maintain and improve surgical skills and knowledge.Ensuring that all medical equipment is properly maintained and in compliance with safety regulations.

Regulatory Affairs Associate I Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate I Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate I, under direct supervision, is responsible for the preparation and revision of high-quality US Gx labeling documents filed under an ANDA and/or 505(b)2, if required, while ensuring adherence to federal regulations and meeting deadlines driven by company goals. Candidate should possess a knowledge of US FDA labeling regulations and guidances to the level of applying them effectively to all work output in addition to developing compliant Structured Product Labeling (SPLs) files with complete drug listing information. How you ll spend your day Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents. Establish SPL for assigned projects. Ensure product data elements align with the required drug listing regulations. Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary. Perform quality reviews of labeling and submission documents by proofreading established labeling files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT. Work with Regulatory Operations as well as in Teva s publishing software to ensure assigned projects are submitted on time following the eCTD requirements related to labeling. Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling. Work in a team environment. Perform all other job-related duties as required by management and dictated by process changes. Your experience and qualifications Bachelor s in pharmacy/Master s in science & Life sciences- 2-3 Years in the Pharmaceutical Industry. Master s in pharmacy-1-3 Years in the Pharmaceutical Industry. Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry with a focus on US Gx labeling. Knowledge of SPL development and drug listing requirements. Be able to multi-task in a fast-paced work environment. Have exemplary oral and written communication skills. Be organized with a keen attention to detail. Have the ability to work independently as well as in a team environment with minimal supervision. Have knowledge of US FDA regulations and guidances related to US Gx labeling. Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions. Proficiency in PC and Microsoft Office Suite, including Microsoft Word and Microsoft Excel. Adobe Acrobat Professional is a must. Familiarity with TVT is preferred. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

About The Role Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Appian Process Automation Good to have skills : NAMinimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will engage in the design, construction, and configuration of applications tailored to fulfill specific business processes and application requirements. Your typical day will involve collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications function seamlessly to enhance operational efficiency. You will also participate in testing and troubleshooting to refine applications, ensuring they meet the highest standards of quality and performance. Roles & Responsibilities:- Expected to perform independently and become an SME.- Required active participation/contribution in team discussions.- Contribute in providing solutions to work related problems.- Assist in the documentation of application processes and workflows.- Engage in continuous learning to stay updated with the latest technologies and methodologies. Professional & Technical Skills: - Must To Have Skills: Proficiency in Appian Process Automation.- Good To Have Skills: Experience with process mapping and optimization.- Familiarity with application lifecycle management.- Understanding of integration techniques with other systems.- Ability to troubleshoot and resolve application issues efficiently. Additional Information:- The candidate should have minimum 2 years of experience in Appian Process Automation.- This position is based at our Coimbatore office.- A 15 years full time education is required. Qualification 15 years full time education

Alembic Group is looking for Senior Manager - Formulation Development to join our dynamic team and embark on a rewarding career journey Delegating responsibilities and supervising business operations Hiring, training, motivating and coaching employees as they provide attentive, efficient service to customers, assessing employee performance and providing helpful feedback and training opportunities. Resolving conflicts or complaints from customers and employees. Monitoring store activity and ensuring it is properly provisioned and staffed. Analyzing information and processes and developing more effective or efficient processes and strategies. Establishing and achieving business and profit objectives. Maintaining a clean, tidy business, ensuring that signage and displays are attractive. Generating reports and presenting information to upper-level managers or other parties. Ensuring staff members follow company policies and procedures. Other duties to ensure the overall health and success of the business.

Alembic Group is looking for Junior Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey They work under the guidance of senior executives and managers to support the organizations goals and objectives Must have excellent written and verbal communication skillsMust be able to analyze complex problems and develop effective solutions Managing internal and external communication, including preparing reports, presentations, and other materials

Alembic Group is looking for Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

Preparation, compilation, and review of dossiers for USFDA and ROW markets ANDAs, amendments, and deficiency responses for the USFDA. Strategize, plan, and oversee USFDA submissions – ANDA, PAS, Annual Reports, and post-approval changes.

Manager Mobility Industrial Join our team in Strategy & Consulting to find endless opportunities and solve our clients' toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Transportation and Logistics, Industrial Consulting, S&C Global Network (GN) I Areas of Work: Mobility & Transport Solutions| Level: Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Explore an Exciting Career at Accenture Are you a problem solver driven by impactful resultsDo you enjoy working on transformation strategies for global clientsDoes a collaborative and inclusive workplace energize you Then, Accenture Strategy & Consulting is where your potential can reach new heights. The Practice A brief Sketch Transportation and Logistics team within S&C GN Industrial Practice brings extensive expertise in driving operational efficiency and digital transformation across global mobility ecosystems. We specialize in digital transformations, end-to-end supply chain optimization, freight and fleet management, route planning and optimization, transportation management systems (TMS) implementation, mobility-as-a-service (MaaS), shared & autonomous mobility services, asset management, process automation and digitization, sustainability initiatives, advanced analytics and data-driven insights, IoT and asset tracking solutions, and industry benchmarking and best practices. Our approach leverages advanced technology to optimize logistics operations, reduce costs, and enhance customer satisfaction, positioning our clients at the forefront of the logistics and transportation industry. Globally, Accenture helps our clients crafting robust transport strategies, driving operational efficiencies, and achieving sustainability goals in logistics. We work on a range of projects, from long-term transformational system integration to short-term agile engagements, supporting our clients with: Mobility Strategy and Transformation: Work with clients to define the vision and roadmap for the future of mobility, focusing on on-demand services, shared & autonomous mobility models, and the seamless integration of mobility services through MaaS platforms. Smart Stations and Terminals Ideation: Lead efforts in designing and developing smart infrastructure solutions for both rail and multimodal hubs that incorporate IoT, digital ticketing, and predictive analytics to improve efficiency, customer experience, and sustainability Enhance Customer Experience: Help clients develop and deploy autonomous rail technologies, on-demand mobility services, multimodal transport systems (e.g., buses, ferries, rail), and high-speed rail systems that enhance flexibility, accessibility, and speed, while improving overall passenger satisfaction and reducing congestion Fleet Electrification: Accelerating adoption of sustainable, electric-powered fleets for various modes of transport including buses and rails, ensuring compliance with environmental regulations Sustainability Mobility :Partner with clients to transition fleets to electric-powered systems, implement energy-efficient routes, and support the adoption of sustainable practices that reduce carbon emissions and ensure compliance with evolving environmental regulations Bring your best skills forward to excel in the role: Skills in one or more of the following areas: Urban Mobility Expertise: In-depth knowledge of multi-modal transport systems (rail, bus, ferry), including high-speed rails, fleet electrification, and shared & autonomous mobility services. Mobility-as-a-Service (MaaS): Experience in integrating on-demand mobility services into existing transport infrastructures, creating seamless connections between multiple modes of transport. Fleet Electrification: Expertise in transitioning fleets (buses, rail) to electric systems, optimizing energy consumption, and reducing emissions. Smart Infrastructure: Knowledge in designing smart infrastructure solutions, smart stations, and bus/ ferry/ air terminals that incorporate the latest digital technologies to enhance efficiency and improve passenger experience. Autonomous and On-Demand Mobility Solutions: Familiarity with the integration of autonomous vehicles and on-demand rail services within existing mobility networks. Sustainability and Green Mobility: Strong understanding of sustainable practices in the rail sector and knowledge of how to implement green mobility strategies in line with industry standards and regulations. Advanced Analytics and IoT Solutions: Ability to leverage IoT, predictive analytics, and data-driven insights to optimize transport operations and asset management. Other required skills: Leadership and Team Development - Ability to lead, mentor, and develop teams, fostering collaboration and creating an environment of growth and continuous learning Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Program management skill with an ability to coordinate cross-functional teams, manage project timelines, and drive successful delivery within scope and budget Cross-cultural competence with an ability to thrive in a dynamic environment Your experience counts! MBA from a Tier 1 or Tier 2 school, or extensive industry experience in mobility services or consulting. 8+ years of progressive experience in mobility solutions, fleet electrification, and MaaS integration. Experience with smart infrstructure, autonomous mobility, and on-demand services. Certifications in Project Management (e.g., PMP, Prince2) and Agile methodologies are an advantage. Familiarity with Agile practices (e.g., Scrum, Kanban) and tools like JIRA to manage projects effectively. Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you An opportunity to work on transformative projects with key G2000 clients Potential to Co-create with leaders in strategy, industry experts, enterprise function practitioners and, business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge and capabilities Opportunity to thrive in a culture that is committed to accelerate equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture: www.accenture.com About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world. come and be a part of our team. Qualification Years of Exp: 8+ years