Executive Regulatory Affairs (API)

Role & Responsibilities
• Prepare and compile API regulatory dossiers in CTD and eCTD formats
• Handle Drug Master File (DMF) submissions, responses, and lifecycle management
• Coordinate with R&D, QA, and cross-functional teams for regulatory documentation
• Review, update, and maintain regulatory documents as per global guidelines
• Support regulatory compliance activities for API products
• Ensure adherence to ICH, USFDA, EMA, and other international regulatory requirements
• Maintain accurate regulatory records and documentation

Qualification
• M.Pharm in a relevant discipline

Experience
• Minimum 1 year of experience in Regulatory Affairs (API)
• Hands-on exposure to API dossier preparation and DMF handling

Skills
• Strong knowledge of API regulatory requirements and global guidelines
• Good documentation and technical writing skills
• Effective communication and interdepartmental coordination abilities
• Attention to detail and regulatory compliance focus

About the Company
• Cadila Pharmaceuticals Limited is a well-established Indian pharmaceutical organisation, Operates across formulations, APIs, and global regulatory markets