Regulatory Affairs - API Leading Pharma - Chennai

Greetings!!! We are seeking an experienced Regulatory Affairs (API) professional with expertise in end-to-end (Pre & Post Approval) regulatory activities for the US market to support product registrations, lifecycle management, and regulatory compliance. Role & responsibilities Pre-Approval Activities Prepare, review, compile, and submit US Drug Master Files (US DMFs) in CTD/eCTD format. Author and review Module 2.3 (Quality Overall Summary) and Module 3 sections for API regulatory submissions. Prepare regulatory documentation for New DMF submissions DMF amendments Annual Reports Letters of Authorization (LOA) Coordinate with R&D, Analytical Development, Quality Assurance, Manufacturing, and Regulatory CMC teams for dossier preparation. Ensure regulatory documentation complies with USFDA, ICH, and FDA Guidance Documents. Review manufacturing processes, specifications, analytical methods, validation reports, stability data, and impurity profiles for regulatory submissions. Evaluate regulatory impact of process changes before submission. Participate in product development meetings to ensure regulatory compliance from the development stage. Support customer queries related to regulatory documentation. Post-Approval Activities Manage lifecycle maintenance of US DMFs. Prepare and submit Annual Reports Amendments Deficiency Responses Information Requests Administrative Updates Evaluate manufacturing, analytical, and process changes for regulatory impact. Prepare and submit CBE-0 CBE-30 Prior Approval Supplements (PAS) Minor and Major Changes Handle deficiency letters, FDA information requests, and customer regulatory queries. Maintain regulatory commitments and submission timelines. Track submission status and ensure timely regulatory compliance. Coordinate product lifecycle management activities. Intrested candidates kindly share your updated CV to dhivakar@bvrpc.com .