Drug Regulatory Affairs Executive
2 weeks ago
Role & responsibilities
- Prepare, compile, and submit dossiers (CTD/eCTD/ACTD formats) for domestic and international markets.
- Coordinate with cross-functional teams (QA, QC, Production, R\&D) to gather and verify required documents.
- Handle regulatory queries from authorities and business partners and ensure timely response and resolution.
- Maintain and update regulatory documentation, product master files, and registration tracking logs.
- Assist in product registration, renewals, and variations as per country-specific requirements.
- Support in preparation of technical documents in compliance with local regulations.
- Stay updated with changes in global regulatory guidelines and notify relevant departments accordingly.
- Participate in audits, inspections, and internal regulatory reviews.
Candidate profile
- Bachelors or Masters degree in Pharmacy
- 5 – 8 years of experience in Regulatory Affairs in the pharmaceutical industry.
- Strong communication, documentation, and coordination skills.
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