Assistant Manager, Regulatory Affairs
Amneal
IndiaPosted Discovered via the company's careers siteMatch locked
Full TimeScientific & QA Jobs
About the role
Description Key Responsibilities: Regulatory Submissions & Documentation Prepare, review, and submit high‑quality regulatory dossiers (IND/IMPD, BLA/MAA, ANDA/Abbreviated MAA where applicable) for global markets including USFDA, EMA. Ensure accuracy and completeness of CTD/eCTD modules, with strong focus on CMC documentation for biologics/biosimilars. Lead responses to regulatory queries, informat
Not included in the source posting: about the role, what you'll do, qualifications, benefits.
Skills
qa
Who can apply
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