Assistant Manager, Regulatory Affairs

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

• 3–10 yrs of experience
• Regulatory affairs
• GMP
• Pharmacovigilance
• Documentation
• Communication
• M.Sc or M.Pharm or PhD