Lead regulatory submissions for tablets and capsules in USFDA, MHRA, EU and UK markets. Manage CTD/eCTD dossiers, product registrations, pre- and post-approval changes, regulatory queries, compliance, and team coordination to ensure timely approvals.
Required Candidate profile
B.Pharm/M.Pharm with 6–10 years’ Regulatory Affairs experience in tablets and capsules, handling USFDA, MHRA, EU/UK markets, CTD/eCTD dossiers, product registration, variations, and team management.