- Prepare, review, and submit regulatory dossiers for product registration, renewal, and variations.
- Compile and maintain dossiers in CTD/eCTD format.
- Central Drugs Standard Control Organization (India)
- United States Food and Drug Administration (US)
- European Medicines Agency (EU)
- Medicines and Healthcare products Regulatory Agency (UK)
- Prepare responses to regulatory authority queries.
- Coordinate with R&D;, Quality Assurance, Manufacturing, Packaging, and Marketing teams.
- Review product labeling, package inserts, artwork, and promotional materials for regulatory compliance.
- Track regulatory changes and implement updates.
- Maintain regulatory documentation and databases.
- Support audits and inspections.
Advantages:
- Life insurance
- Paid sick time
- Provident Fund
Work Location: In person
📌 Drug Regulatory Affairs (India)
🏢 Damaira Pharmaceuticals
📍 India
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