Job openings for Regulatory Affairs Manager in Vile Parle East Mumbai

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 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.
• Assist in launching new veterinary pharmaceutical products by obtaining regulatory approvals