Executive / AM - Regulatory Affairs
- Vadodara, Gujarat
- Permanent
- Full-time
- Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines.
- Ensure timely submission and follow-up of applications with regulatory authorities.
- Maintain up-to-date knowledge of changes in drug regulatory environments and communicate impacts to relevant departments.
- Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation.
- Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards.
- Assist in handling product labelling, artwork approvals, and packaging compliance.
- Respond to regulatory queries and deficiencies from health authorities in a timely manner.