Manager- International Regulatory Affairs
5 days ago
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
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