Officer RA (Regulatory Affair)-Pharma API Industry

Key Responsibilities

• Assist in preparation and submission of regulatory dossiers such as USDMF, CEP, and ASMF
• Handle amendments, annual reports, and lifecycle management of regulatory filings
• Respond to queries from regulatory authorities and ensure timely resolution
• Prepare and maintain Drug Master Files and related documentation
• Coordinate with internal departments for data collection and submission readiness
• Manage vendor documentation and ensure compliance with regulatory standards
• Maintain and update regulatory databases and tracking systems
• Ensure adherence to global regulatory guidelines and compliance requirements
• Support audit readiness and documentation reviews