- Handle regulatory activities for pharmaceutical products in export markets.
- Prepare, review, and manage regulatory dossiers and submission documents.
- Manage product registrations, renewals, variations, and regulatory updates for international markets.
- Coordinate with QA, QC, R&D;, Production, and other departments for required regulatory documents.
- Prepare responses for regulatory queries and deficiencies from overseas regulatory authorities.
- Review product artwork, labeling, and packaging materials as per country requirements.
- Maintain regulatory documentation, trackers, and registration records.
- Ensure compliance with country-specific regulatory guidelines and requirements.
Required Skills & Qualifications:
- B.Pharm / M.Pharm or equivalent qualification preferred.
- 2–3 years of experience in Regulatory Affairs – Export Markets (Pharmaceutical Industry).
- Hands-on experience in regulatory submissions and dossier preparation.
- Valuable knowledge of international regulatory requirements and documentation.
- Strong documentation, communication, and coordination skills.