Assistant Manager, Regulatory Affairs
IndiaFull-time3–10 yrsPosted 1 week ago
Mid-level pharma role at Hcfa. Needs 3+ years and an M.Sc, M.Pharm or PhD.
About the role
Assistant Manager, Regulatory Affairs at Hcfa. Regulatory Submissions & Documentation.
What you'll do
- 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, information requests, and deficiency letters within stipulated timelines
- Regulatory Strategy & Development Support
What you need
- Regulatory affairs
- GMP
- Pharmacovigilance
- Documentation
- Communication