Manager- international regulatory affairs

1 week ago


Navi Mumbai, India Domnic Lewis International Full time
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
e CTD, 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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