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.
Perks:
Life insurance
Paid sick time
Provident Fund
Work Location: In person
📌 Drug Regulatory Affairs Panchkula (India)
🏢 Damaira Pharmaceuticals
📍 India
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