Assistant Manager, Regulatory Affairs

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.