6 - 7 years
8 - 10 Lacs
Posted:4 hours ago|
Platform:
Work from Office
Full Time
1. The candidate will be responsible for the preparation and review of product registration and renewal dossiers (CTD/ACTD) for various ROW markets.
2. The candidate will be responsible for understanding, interpreting, and implementing regulatory guidelines for different ROW countries.
3. The candidate will be responsible for preparing and renewing registrations, manufacturing licenses, product permissions, WHO-GMP certificates, MSO registrations, and other regulatory documentation required by ROW authorities.
4. The candidate will be responsible for leading the preparation, review, and submission of regulatory documents to relevant health authorities across ROW markets.
5. The candidate will be responsible for submitting required information, responses, and clarifications to regulatory authorities within defined timelines.
6. The candidate will be responsible for obtaining market-specific approvals such as product permissions, test licenses, plant approvals, free sale certificates, COPPs, and other necessary clearances.
2. The candidate should have strong experience in preparing and reviewing CTD/ACTD dossiers for registration and renewal in ROW regions.
3. The candidate should be responsible for preparing and submitting applications to overseas regulatory authorities and following up through local agents, distributors, or manufacturers as required.
4. The candidate should be responsible for reviewing artworks to ensure compliance with regulatory, country-specific labeling, and pharmacopoeial requirements.
5. The candidate should be responsible for ensuring regulatory compliance as per guidelines applicable in ROW markets and maintaining updated knowledge of changing regulations.
HRD House
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