Senior Regulatory Affairs Executive Deccan Nutraceuticals

2.0 - 5.0 years

4 - 8 Lacs

Pune

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Job Description We are hiring a Senior Regulatory Affairs Executive with around 5 years of experience in regulatory submissions for international markets, especially USFDA and EDQM . This role involves end-to-end regulatory dossier preparation and submission, technical data coordination, and maintaining compliance with global regulatory standards in an API manufacturing environment. Key Responsibilities Prepare, compile, and submit regulatory dossiers (DMFs, CEPs, ASMFs) to international authorities, focusing on EDQM and USFDA. Coordinate cross-functionally with R&D, QA, QC, and Production teams for document and data collection. Maintain submission timelines and follow-up systems for timely responses and approvals. Provide regulatory intelligence, evaluate changing guidelines, and ensure compliance for ongoing projects. Handle deficiency responses and audits with strong documentation and archiving practices. Act as a regulatory liaison with internal and external stakeholders. Job Location : Innov8 Suman Business Park Kalyani Nagar Pune Apply to: recruitment@dnplfactory.com Contact No: 8956760759

Posted 1 month ago

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API Regulatory Professional RL Fine Chem (RLFC)

10.0 - 15.0 years

12 - 17 Lacs

Bengaluru

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Qualification: MSc in Analytical / Organic Chemistry Pharmacy Life Science Role Summary: Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance. Key Responsibilities: Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities. Ensure timely updates, maintenance, and life cycle management of submissions. Monitor global regulatory changes and communicate to internal teams. Handle customer queries, letters of access, and technical data packages. Maintain database and tracking systems for submissions and commitments. Support regulatory and customer audits across all sites. Key Skills & Competencies: Passion to make a difference combined with : Strong analytical and strategic thinking. High attention to detail and ability to manage multiple projects/filings. Excellent written and verbal communication. Experience with Electronic Submission System (eCTD). Knowledge of pharmaceutical standards (USP, EU, JP). Understanding of documentation and filing requirements (US-FDA, EDQM, ANVISA, PMDA, etc.). Familiarity with ICH Q7, M7, Q11, Q12 guidelines.

Posted 2 months ago

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Walk in Drive API Regulatory Affairs Dept (RA). MSN Group

1.0 - 6.0 years

2 - 7 Lacs

Hyderabad/Secunderabad

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Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana Interview Date:- 05-07-2025 @Saturday Interview Time :- 9AM TO 2PM Venue Details : MSN Laboratories Pvt. Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry. Key Responsibilities: Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals. Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance. Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required. Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities. Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations. Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management. Position : Executive Qualification : M.sc Work Location : MSN R&D Center, Pashamylaram. Department : API Regulatory Affairs Dept - ( API RA ) Experience : 1 to 7 Years Job Location : MSN Laboratories Pvt.Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy Interested Candidates can share there CVs to dinesh.baratam@msnlabs.com

Posted 2 months ago

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API Regulatory Affairs Executive / Officer Harman Finochem

5.0 - 10.0 years

5 - 12 Lacs

aurangabad

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Hi, We have opening for the position of API regulatory affairs department for API Manufacturing industry. Role & responsibilities 1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries 2. Submission of DMF amendments and variation filings to implement the post approval changes 3. Evaluation of change controls and perform regulatory assessment based on submitted DMF 4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose. 5. To Maintain regulatory database by following best regulatory practices 6. To prepare action plan for Defficiency letter response and timely Respond to defficiency letters 7. To provide Best in class API regulatory support to Customer 8. Knowlege of current regulatory guidelines and ICH guidelines Preferred candidate profile Experience - 05 to 12yrs, Education: M.Sc- Chemistry Preferred only API Pharma industry experience profile. Interested candidate can share their profile on email id amrutar@harmanfinochem.com

Posted Date not available

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