Manager Regulatory Affairs

Requirements

• Knowledge on Regulatory guidelines for API & Finished product registration.
• Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) and DMF for Regulatory and Non Regulatory Markets.
• Lead and manage activities concerned with the submission and approval of products and product transfers to government regulatory agencies
• Functioning as a liaison between the company and government agencies for assigned projects
• Oversee applications for nutraceutical products in compliance with FSSAI regulations, ensuring product composition aligns with regulatory standards.
• Build strong regulatory and technical internal expertise
• Coordinate with cross functional departments to ensure compliance