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8.0 - 12.0 years

0 Lacs

hyderabad, telangana

On-site

Role Overview: As an experienced analytical development scientist at Dr. Reddys Laboratories Ltd., your main responsibility will be to execute analytical activities based on priorities and established timelines. You will be required to 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. Key Responsibilities: - Conduct Literature survey and prepare analytical strategy for assigned projects. Should have a minimum understanding of DMF and test methods of drug substance, etc. - Perform analytical method development of Viscosity, PSD, GSD, Assay, RS, preservative content, residual solvents, rheology, IVRT etc. - Conduct method validation and method development. Prepare new specifications/STPs and COAs. Integrate inputs from QA, QC, and RA members. - Execute method feasibility studies for compendia procedures of excipients/API/FP. - Ensure analytical methods and process compliance as per quality assurance requirements. - Perform calibration or performance verification of analytical equipment. Maintain and standardize reference or working standards. Check for the availability and validity of the Impurities. - Execute assigned day-to-day routine analysis of development, stability samples, scale-up, PE batches. - Coordinate with other departments (CFTs) for procurement, analytical method transfer activities, specification finalization, etc. - Perform method transfers to plant QC, customers, or Third-party labs for projects and support at the time of exhibit/submission batch execution. - Adhere to safety guidelines, applicable ISMS guidelines, SOPs, equipment usage, and maintenance procedures. - Conduct studies at external CRO labs to manage peak workloads or when internal capabilities are not available. Provide technical support to CRO labs for smooth execution of studies. Qualification Required: - Education Qualification: MSc Chemistry, M Pharm Chemistry - Minimum experience required: 8-12 years of experience in analytical development department and must have worked on the nutritional product portfolio. Additional Details: Dr. Reddys Laboratories Ltd. is a leading multinational pharmaceutical company with a commitment to access, affordability, and innovation. With a focus on sustainability and reaching over 1.5 Bn+ patients by 2030, the company aims to be purpose-driven, future-ready, and sustainable. The company's work culture fosters empathy, dynamism, and teamwork, where individual abilities are supported in a shared success environment. Visit the career website at https://careers.drreddys.com/#!/ for more information.,

Posted 13 hours ago

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11.0 - 16.0 years

16 - 18 Lacs

ahmedabad

Work from Office

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

Posted 21 hours ago

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5.0 - 7.0 years

6 - 8 Lacs

vadodara

Work from Office

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna. Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement. To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement. Responsible for prepare and review Drug Master File as per respective reulatory agency guidline. Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies. To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline. Responsible for prepare Drug Master File (DMF) Deficiency response to respective regulatory agency. Responsible for prepare Drug Master File (DMF) Amendment report to respective regulatory agency. Responsible for prepare Drug Master File (DMF) Annual update report to respective regulatory agency. Assessment and notification of change to regulatory agency and customer as per regulatory requirement. Aim to serve as an internal API regulatory expert, ensuring regulatory compliance within the cross-functional teams. Responsible for scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements including continuous improvement programs.

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3.0 - 11.0 years

7 - 8 Lacs

pune

Work from Office

Johnson Controls is looking for Sr. Analyst - RTR EMEA to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Posted 3 days ago

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6.0 - 10.0 years

7 - 16 Lacs

gurugram

Hybrid

Area Of Responsibility - To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements. - To review outsourced intermediates and APIs for regulatory adequacy to support Procurement Team in vendor selection and DF-Regulatory for ANDA/MA submission. - To coordinate & support Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies for regulatory submissions as well as for responding regulatory queries. - To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner. Deliverables - Compilation and review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updation. - Preparation and review of Regulatory Amendments / Variations for smooth API supplies - Preparation of responses to regulatory deficiencies - Regulatory support to Chemical Research Department, Analytical Department, Chemical manufacturing, Quality Assurance, Procurement Team and Regulatory Affairs-Pharma - Ensure reposition of regulatory database and compliance to departmental guidelines.

Posted 5 days ago

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1.0 - 5.0 years

0 Lacs

vadodara, gujarat

On-site

As a Jr. Officer to Sr. Officer at our company, you will be responsible for the following: - Preparation of dossiers and documents in compliance with CTD, ACTD, and country-specific guidelines. - Reviewing dossiers, DMF, and technical documents. - Addressing queries raised by regulatory authorities. Qualification Required: - Must have an M.Pharm degree. The work location for this position is in Jarod, Vadodara, Gujarat. Additionally, we offer benefits such as health insurance, leave encashment, life insurance, paid sick time, and provident fund. Please note that this position requires a long-term association agreement with an incentive scheme for 2-3 years.,

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2.0 - 5.0 years

3 - 7 Lacs

navi mumbai

Work from Office

Job Description Responsible for submissions of Response to Deficiencies to Health Agencies of Europe, Australia, New Zealand and Canada market and Customers. Responsible for post approval submissions to Europe, Australia, New Zealand and Canada market. To provide Regulatory inputs during inspections by Regulatory authorities and Customer as and when required. To provide Regulatory inputs during product development, manufacturing and testing and to evaluate all types of change proposals during product life cycle Work Experiance Should have worked in Regulatory Affairs Dept for regulated markets like EU/UK, Australia, Canada, US etc (minimum 1-2 years). Submission of new submissions, deficiency responses and/or post-approval submissions for above markets. Worked on various dosage forms including complex generics. Compilation of Module 2 and 3 CTD sections for above submissions. Review of documents for all these sections. Knowleage of ICH as well as country specific guidance for documents to be submitted in all above sections. Hands on experiance for ECTD compilation. Competencies Strategic Agility Process Excellence Collaboration Innovation & Creativity Result Orientation Stakeholder Management Customer Centricity Developing Talent Education Masters Graduation in Pharmacy or Science

Posted 6 days ago

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0.0 years

0 Lacs

mumbai, maharashtra, india

Remote

Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA, ISO 13485, ICH guidelines). The ideal candidate will have a strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration to support product development, registration, and commercialization. Key Responsibilities: Prepared, reviewed, and submitted regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications. Ensured compliance with international, federal, and local regulatory requirements across pharmaceuticals and medical devices. Interacted with regulatory authorities (FDA, EMA, CDSCO, MHRA, Notified Bodies) during product submissions, inspections, and audits. Developed and maintained regulatory strategies to support new product development and lifecycle management. Reviewed labeling, promotional materials, and product packaging for compliance with applicable regulations. Maintained up-to-date knowledge of regulatory changes, guidelines, and industry best practices to ensure organizational compliance. Supported quality systems in alignment with ISO 13485, ICH, and FDA QSR standards. Collaborated with R&D, Quality, Manufacturing, and Clinical teams to integrate regulatory requirements into product development. Assisted in responding to regulatory queries, deficiency letters, and inspection findings. Managed regulatory documentation archives and maintained compliance records for audits and inspections. Show more Show less

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0.0 - 2.0 years

2 - 6 Lacs

mumbai

Work from Office

Job Responsibilities- Assisting in developing audit planning documentation addressing scope,auditobjective, budgeted hours, resource plan,and reporting date Complete assignedaudits, addressing allauditobjectives, conducting clientandstatus meetings as required, controlling, monitoring,and reporting onauditprogress, reviewing work papers,and ensuring work papers provide adequate support of conclusions while complying with internal standards for documentation. To monitor the assignment for improving the efficiency of the assignment, manageauditin relation to time and resource budget Will actively check that all findingsandissues are documentedandperform closedown procedures Gatheringandcompiling informationanddata Excellent interpersonal and communication skills, including good presentation and report- writing skills Develops and maintain strong relationships across all levels of the organization Provides recommendations for strengthening controls Ability to deal well with ambiguityandconstant change as well as working independently A solid understanding of IGAAP, INDAS,andthe Companies Act You should have and demonstrate the capability to think conceptually, visualize different scenarios and decide based on analysis and logical reasoning.

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10.0 - 20.0 years

20 - 25 Lacs

hyderabad

Work from Office

Position: AGM Quality Location: Hyderabad Key Responsibilities Lead quality initiatives across plastics processing and molding operations Manage pharma packaging quality and ensure regulatory compliance (DMF filing, ISO, GMP, 15378, etc.) Must Drive process improvements, audits, and risk assessments across multiple units Handle customer and agency audits (USFDA, Health Canada, China DMF, ISO certifications) Implement problem-solving methodologies (Six Sigma, FMEA, RCA, CAPA, SPC, QC tools) Reduce customer complaints, internal rejections, and standardize best practices across sites Partner with plant leadership to execute technical improvement plans, automation, and quality infra upgrades Support new product development with strong validation and compliance frameworks Build a culture of quality through training, engagement, and continuous improvement Requirements 10–15 years of experience in pharma plastic packaging or related industry BE/B.Tech/PG Strong exposure to regulatory compliance, process audits, and multi-unit operations Excellent analytical, problem-solving, and communication skills

Posted 2 weeks ago

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1.0 - 5.0 years

5 - 12 Lacs

chennai

Work from Office

review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDA Review of DMF; Manages USFDA registration Provides technical review of data and reports to be incorporated into regulatory submissions;

Posted 2 weeks ago

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1.0 - 5.0 years

0 Lacs

hosur, tamil nadu

On-site

You are invited to join Global Calcium Pvt. Ltd., a prominent API manufacturing company located in Bangalore, India, specializing in speciality API's, benzodiazepines, ophthalmics, oncology, chelated minerals, and organic mineral salts. We are currently seeking talented individuals to fill various roles in the QC Department. Open Positions: - QC ICP-MS Analyst (2 openings) - QC DMF Support (2 openings) - QC Analytical Validation Support (2 openings) - QC Wet Analysis (2 openings) Qualifications: - B.Sc./M.Sc. in Chemistry or related fields - 1 to 4 years of relevant pharmaceutical QC experience - Familiarity with cGMP practices and regulatory compliance Responsibilities: - Perform routine and non-routine analyses using analytical techniques and instruments - Develop and validate analytical methods and protocols - Prepare and maintain detailed documentation and reports - Ensure adherence to regulatory guidelines and GMP standards - Collaborate with other departments for cross-functional projects - Participate actively in laboratory investigations and troubleshooting activities Walk-in Interview Details: - Venue: Global Calcium Pvt. Ltd., Unit III, 19 & 19B, Sipcot Industrial Complex, Phase - 1, Dharga, Hosur - Date: 14th June 2025 - Time: 9:30 AM to 11:00 AM Please note that only candidates with relevant experience in the pharmaceutical QC domain will be considered for these positions. Benefits and Perks: - As per industry standards If you possess the required skills and experience in DMF preparation, UV, regulatory documentation, elemental impurity analysis, cGMP practices, HPLC, GC, classical wet chemistry techniques, quality control, ICP-MS, wet analysis, and method validation techniques, we encourage you to attend the walk-in interview and become a part of our dynamic team at Global Calcium Pvt. Ltd.,

Posted 2 weeks ago

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4.0 - 5.0 years

1 - 4 Lacs

bawal

Work from Office

Sodexo Food Solutions India Pvt. Ltd. is looking for Operator - Stp & Wtp to join our dynamic team and embark on a rewarding career journey Responsible for coordinating all work requests coming in through e mail, phone or any other form of communication regarding the services provided to the client by Sodexo Key Responsibilities Collaborate with other members of the Sodexo on site team, to dispatch as well as collect the work orders established after receiving a request through mail/phone/paper. Collect all closed work orders to close the calls. Produce reports based on the data collected, through produced work orders, for Sodexho and the Client Receive and answer all incoming calls/mails/papers reporting complaints or work requests Log in the call through the software, which in term generates work orders Set up reports with all collected data coming from the work orders for the Client as well as for Sodexo for controlling, transparency and information purposes Maintain the helpdesk work area and equipment in a clean and orderly condition following all prescribed regulations Maintain the confidentiality and security of all data and information relating to the facility Maintain professional appearance at all times

Posted 2 weeks ago

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1.0 - 2.0 years

2 - 3 Lacs

sriperumbudur

Work from Office

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

Posted 2 weeks ago

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6.0 - 8.0 years

2 - 3 Lacs

oragadam

Work from Office

WTP OPERATORFollow daily shift activates without deviations. Follow daily operations and logbooks updation as per SOP. Please coordinate with MAC and calibration activity with internal team. WTP snatization activates as per schedule'

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5.0 - 7.0 years

8 - 12 Lacs

chennai

Work from Office

The Impact You'll Make As a financial controller within our dynamic finance organisation, you'll play a pivotal role in driving the financial strategy for a substantial ?1 3 billion division Your contribution will not only enhance our financial planning and forecasting capabilities but also significantly bolster our risk management efforts By collaborating closely with product line leaders, you will be instrumental in delivering actionable insights that can transform data into strategic opportunities You will be at the forefront of identifying and modelling financial risks, thus helping to steer performance targets towards successful outcomes Your expertise will aid in shaping decisions that directly impact our business and ensure our financial health is robust and sustainable, What Youll Be Doing Assist in the comprehensive development of the annual budget, quarterly forecasts, and long-range strategic planning initiatives for specific product lines, ensuring alignment with broader corporate goals, Consolidate financial submissions from various business units, meticulously reviewing them for accuracy, consistency, and adherence to corporate objectives, thus fostering transparency across departments, Identify and assess financial risks that could affect the product line, including market fluctuations, operational challenges, cost variability, and currency impacts, providing a comprehensive risk profile to guide decision-making, Conduct in-depth scenario analyses and sensitivity studies to evaluate potential impacts of market changes, equipping leadership with the foresight needed to navigate uncertainties, Propose effective mitigation strategies and implement financial controls that enhance operational integrity and financial resilience, Support strategic initiatives?including pricing adjustments, tariff evaluations, and capital investment assessments?through advanced financial modelling and return on investment (ROI) analyses to ensure maximised value, Communicate insights and present findings to senior leadership, empowering informed decisions that drive the organisation forward, Collaborate proactively with operational teams to unearth cost-saving initiatives and improve efficiencies across processes, thereby contributing to overall operational excellence, Maintain compliance with corporate financial policies, accounting standards, and regulatory requirements to uphold the highest integrity within our financial practices, What We're Looking For A Bachelor's degree in finance, accounting, economics, or a related field is essential, with preference given to candidates possessing professional certifications such as CPA, CMA, or CIMA, A minimum of 8 years of relevant experience in financial planning, controlling, or product line finance, ideally acquired within a manufacturing or product-focused environment, showcasing a strong understanding of industry standards, Demonstrated proficiency in financial modelling, risk analysis, and performance metrics, with the capability to apply these skills effectively within a corporate context, Expertise in ERP and reporting systems, specifically SAP, HFM, or similar platforms, along with advanced skills in Excel and Power BI to perform complex data analyses, Exceptional analytical, problem-solving, and communication skills, ensuring clear and effective dialogue with various stakeholders across the organisation, Cultural agility and the ability to influence cross-functionally without direct authority, leading to collaborative outcomes that drive the business forward, A meticulous attention to detail, with the capability to manage multiple priorities and work efficiently within tight deadlines, ensuring that financial objectives are consistently met, Ready to Make a Difference If this role excites you, wed love to hear from you! Apply now to start the conversation and learn more about where your career can go with us, All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or other protected category,

Posted 2 weeks ago

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8.0 - 12.0 years

8 - 15 Lacs

vadodara

Work from Office

Experience of DMF & Regulatory Documentation of Export Market.

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3.0 - 5.0 years

2 - 6 Lacs

bengaluru

Work from Office

About The Role Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the world s leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs LCM tasks of building dossiers and Coordination for LCM activities accordance with ICH and Global Requirements and guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components.Collect, collate and evaluate the scientific data gathered as part of R & D. Advise on scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example Build regulatory submission strategy, author regulatory documents, and health authority packages etc. What are we looking for? Life Sciences Regulatory ServicesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamAgility for quick learningVeeva Vault and Regulatory Life Sciences Requirements Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

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13.0 - 23.0 years

14 - 24 Lacs

hyderabad

Work from Office

Academic Background and Experience: Academics - M.Sc. in Chemistry Experience 13 to 25 years Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities Review documents from various departments to compile regulatory submissions. Oversee Drug Master Files (DMFs) for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMFs to ensure regulatory compliance. Coordinate with cross-functional teams (CFT) to address deficiencies and feedback from regulatory authorities and customers. Conduct CFT meetings to ensure timely responses to regulatory deficiencies and customer inquiries. Provide regulatory guidance to product development teams and attend Technology Transfer Meetings to support compliance. Maintain and update regulatory databases, ensuring accuracy and completeness. Review and approve regulatory submissions and related documents prepared by team members for compliance. Manage change controls and other relevant documents, including approving them in the HOD's absence. Respond promptly to technical queries from regulatory bodies and customers. Interested candidates share their CV to dinesh.baratam@msnlabs.com Please mention subject line "API RA Manager/Sr Manager/AGM profile"

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3.0 - 8.0 years

2 - 4 Lacs

vadodara

Work from Office

Responsibilities As a regulatory affairs officer: ensure that a company's products comply with the regulations of the regions where they want to distribute them keep up to date with national and international legislation, guidelines and customer practices respond to queries from medical bodies like the Medicines and Pertaining to that Guidelines. collect, collate and evaluate scientific data from a range of sources develop and write clear arguments and explanations for new product licences and licence renewals prepare submissions of licence variations and renewals to strict deadlines monitor and set timelines for licence variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data advise scientists and manufacturers on regulatory requirements provide strategic advice to senior management throughout the development of a new product project manage teams of colleagues involved with the development of new products oversee product trials and interpret trail data undertake and manage regulatory inspections review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities negotiate with regulatory authorities for marketing authorisation take part in the development of marketing concepts and approve packaging and advertising before a product's release. Role & responsibilities Preferred candidate profile

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8.0 - 10.0 years

6 - 8 Lacs

navi mumbai

Work from Office

Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures. Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc. Filing amendments, updates with relevant health agencies Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software Preparation of response to queries received from health authorities and customers Evaluation of regulatory impact and review of QMS documentation Coordination with various stake holders at site for documentation Participation in project review meeting regarding new products and providing regulatory feedback Licensing Activities: Interaction with Licensing authorities Monitor and maintain all valid licenses as per Drug and Cosmetic act. 1940 and Rules 45. Applications for new licences according to requirements. Online applications on NSWS/ SUGAM portal. Monitor and maintain all documents as per NDPS act. 1985. Monitor and maintain Legatrix activities Monitor and maintain Loan Licenses certificate and approvals.

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0.0 - 1.0 years

3 - 6 Lacs

coimbatore

Work from Office

Role / Nature of Job : Assembly / Machine Operator Follow and support Safety and Environmental practices on the shop floor, including hazard identification and safe working methods, in line with ISO45001 & ISO14001 standards. Operate machines and follow established processes after required training, ensuring adherence to ISO9001:2015 standards. Support shift production targets by executing assigned operations and coordinating with relevant support teams. Maintain discipline in resource usage to support cell-level productivity and cost control (Volume-adjusted VOH). Carry out production activities as per the shift plan to meet internal customer requirements. Build skills through On-the-Job Training (OJT) and take responsibility for multiple tasks as part of multi-skilling efforts. Assist in tracking and reporting key manufacturing performance indicators (KPIs). Apply Lean principles in daily work and actively contribute improvement ideas to relevant stakeholders. Work on machines such as CNC Horizontal Turning Centers, OD Grinding, HMC, and CNC Gear Grinding as assigned / Assembly line to meet the necessary target. Safely handle heavy components using overhead cranes and follow proper placement procedures. Read and understand engineering drawings and apply them in part machining and inspection. Follow 5S, FIFO, Kanban, CIS, and Kaizen practices in day-to-day operations. Your Profile : Diploma / BE.,(from Tier 3 or 4 college) in Mechanical / Automobile/ Manufacturing/ Production/ Metallurgy / Agriculture 0 - 1 Years experience in Production / Assembly as Operator Be part of our ZF team as Assembly / Machine Operator and apply now!

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3.0 - 7.0 years

3 - 8 Lacs

khandala, pune

Work from Office

Role & responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOAs for US-FDA, Health Canada and NMPA China. Maintain LOA data base, prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats. Arrange samples and testing data required for submission Support RA Manager in preparation of dossiers and preparing response to the Health Authorities Manage timely notarization and legalization of quality certificates/ documents Maintain ISO database & support Datwyler employees in obtaining working copies of standards Track list of standards for updates / revisions & support implementation of revised standards (change control process) Demonstrate strong competence pertaining to regulatory knowledge like pharamcopoeial requirements (USP, EP, JP, ChP), regulatory guidelines issued by EU, USA, China, Canada, ICH & other health authorities Keep abreast with the new updates from Health Authorities like FDA warning letters, authorization of innovative products, etc. Provide regulatory support to Datwyler employees and customers Participate in different internal projects for regulatory support Update internal trainings for employees Preferred candidate profile Master or Bachelor degree in a scientific discipline (chemistry, biochemistry, biomedical sciences, biology,...) plus 3 years of experience in Regulatory Affairs or R&D or QA/QC in pharmaceutical packaging components or pharmaceutical industry Willing to develop detailed regulatory knowledge about packaging components, specifically rubber but also aluminium Entertaining frequent internal contacts with colleagues in various departments (R&D, Sales, Quality, ..) and in various parts of the world (Europe, China, USA) Skilled in eCTD dossier preparation & technical writing Punctual in maintenance and storage of regulatory files and documents Partially working from home/office (after training period) Only sporadic traveling (less than 5 % of working time) Good spoken and written English

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5.0 - 10.0 years

4 - 8 Lacs

ahmedabad

Work from Office

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Preferred candidate profile Hiring for API & Formulation background candidates for Regulatory Affairs Team Good Communication Skill in English

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3.0 - 4.0 years

2 - 6 Lacs

hyderabad

Work from Office

Follow daily shift activates without deviations Follow daily operations and logbooks updation as per SOP Please coordinate with MAC and calibration activity with internal team WTP snatization activates as per schedule

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