Sun Pharma is hiring an Executive for India Regulatory Affairs in Vadodara. You will evaluate regulatory documents, compile dossiers and submit them to CDSCO for approval of drug substances and drug products. The role covers evaluating regulatory strategies for products registered in India, reviewing CMC documents with cross-functional teams, preparing cover letters and applications on the regulator's portal for clinical trial, BE, manufacturing, marketing and import approvals, compiling IPC testing dossiers and handling post-approval changes.
Requirements: a B.Pharm or M.Pharm with a minimum of 2 to 5 years of relevant regulatory affairs experience.