Key Responsibilities
- Prepare, review, and submit product registration and renewal dossiers (CTD/ACTD) for ROW markets
- Understand, interpret, and implement regulatory guidelines applicable to different ROW countries
- Prepare and renew registrations, manufacturing licenses, product permissions, WHO-GMP certificates, MSO registrations, and other required regulatory documentation
- Lead the preparation, review, and submission of regulatory documents to relevant health authorities across ROW markets
- Submit required information, responses, clarifications, and variations to regulatory authorities within defined timelines
- Obtain market-specific approvals such as product permissions, test licenses, plant approvals, free sale certificates, COPPs, and other necessary clearances
- Review product artworks to ensure compliance with regulatory requirements, country-specific labeling norms, and pharmacopoeial standards
- Ensure ongoing regulatory compliance and stay updated with changing regulations in ROW markets
Preferred Candidate Profile
- B.Pharm or M.Pharm graduate
- 78 years of experience in Regulatory Affairs for pharmaceutical formulations, specifically handling ROW markets
- Strong experience in preparation, review, and lifecycle management of CTD/ACTD dossiers for registration and renewal in ROW regions
- Experience in preparing and submitting applications to overseas regulatory authorities and coordinating with local agents, distributors, or manufacturers
- Strong knowledge of regulatory compliance, labeling requirements, and pharmacopoeial standards for ROW markets
- Excellent communication, coordination, and stakeholder management skills
