Drug Regulatory Affairs Jobs

Should have good knowledge of preparing Dossier of Drugs & Feed Supplements in different countries Managing regulatory affairs of the organization & its subsidiaries / associates. Liaising with regulatory bodies like State and Central FDA, DCI, etc. Well conversant with Drug law/feed supplement regulation. Compilation and preparation of tender documents. Coordinating documents & process for Audit. FDA Documentation & Portal handling. FSC, legal action and other statutory document perpetration and compilation.

Urgent OpeningRegulatory Affairs Manager (Veterinary Pharmaceuticals)Veterinary Pharmaceutical Manufacturing CompanyPalghar, MaharashtraQualification B.Pharm / M.Pharm / M.V.Sc. / M.Sc. or an equivalent qualification. Additional certification in Regulatory Affairs will be an added advantage. Experience 8-12 years of experience in Regulatory Affairs within the veterinary or pharmaceutical industry. Experience in handling product registrations and regulatory approvals. Regulatory Affairs Manager to oversee all regulatory activities for veterinary pharmaceutical products. The candidate will be responsible for product registrations, dossier preparation, regulatory submissions, license management, and ensuring compliance with all applicable veterinary pharmaceutical regulations.Key Responsibilities Manage regulatory affairs activities for veterinary pharmaceutical products. Prepare, review, and submit product registration dossiers to regulatory authorities. Coordinate with the CDSCO, State FDA, and other regulatory authorities for approvals and licensing. Ensure compliance with the Drugs and Cosmetics Act & Rules, Schedule M, GMP, and other applicable regulations. Prepare and maintain regulatory documentation, technical files, and product dossiers. Handle applications for manufacturing licenses, product permissions, and renewals. Coordinate with QA, QC, Production, R&D, and Marketing departments for regulatory compliance. Review product labels, package inserts, and artwork to ensure regulatory compliance. Respond to regulatory queries and deficiency letters from authorities. Monitor changes in regulatory guidelines and implement necessary updates. Support internal, customer, and regulatory audits. Maintain regulatory records and ensure timely submission of required documents. Required Skills Strong knowledge of Veterinary Pharmaceutical Regulations. Experience in CDSCO, State FDA, and product registration processes. Knowledge of Drugs and Cosmetics Act & Rules, Schedule M, and GMP. Ability to coordinate effectively with cross-functional teams and regulatory authorities.