Domnic Lewis International | Manager- International Regulatory Affairs
1 week ago
We are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.
Position: Manager- International Regulatory Affairs
Experience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)
Qualification: M. Pharm or B. Pharm
Responsibilities:
- Prepare and review CTD and ACTD dossiers.
- Coordinate with Plant and R&D to gather inputs necessary for regulatory submission.
- Ensure plant compliance with regulatory standards.
- Achieve monthly plan goals and promptly respond to queries.
- Perform gap analysis and update Master data.
- Review Change Controls, Stability Protocol, Clinical Trial Protocols, and Artworks.
- Solicit feedback from all countries regarding respective variations and ensure their timely submission.
- Manage renewals.
- Update Master data.
- Conduct regular follow-ups with the plant for documentation and review meetings.
- Track and review document requirements for upcoming new filings in ROW and Emerging markets.
Knowledge and skills
- eCTD, CTD, Validation, ICH requirements, USFDA Filings,
- WHO Prequalification, MCC South Africa for Biological and
- Biotech products
- Has exposure to in-licensed dossier filing and out licensing
Interested candidate can reach out to me at pooja.j@domniclewis.com
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navi mumbai, India Domnic Lewis International Full timeWe are looking for a Manager- International Regulatory Affairs for a Bio-pharmaceutical giant based in Navi Mumbai.Position: Manager- International Regulatory AffairsExperience: 7+ years in regulatory affairs (must have experience in biosimilars or biologic products)Qualification: M. Pharm or B. PharmResponsibilities:Prepare and review CTD and ACTD...
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