Executive - Regulatory Affairs
4 days ago
Job Location: Delhi
Key Responsibilities
- Prepare, review, and maintain regulatory documentation (dossiers, registration files, certificates, product information, etc.)
- Coordinate with sales & marketing team to collect required documents and information for product registrations and submissions.
- Liaise with the factory regulatory department to ensure timely preparation and availability of technical files, test reports, and supporting documents.
- Assist in submission of product registration, renewals, and regulatory approvals as per international requirements.
- Maintain regulatory records, approvals, and databases for accuracy and completeness for each International customer/ market.
- Support in responding to regulatory queries from international customers or distributors.
- Ensure all documents follow company SOPs, regulatory guidelines, and quality system requirements.
- Provide regular status updates of ongoing regulatory submissions to sales teams and management.
Qualifications & Skills
- Bachelors degree in Pharmacy, Life Sciences, Biotechnology, or related discipline.
- 3- 5 years of experience in Regulatory Affairs / Documentation (Medical Devices or Pharmaceuticals preferred).
- Strong documentation and record-keeping skills.
- Good coordination and communication abilities to work across teams.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).
- Detail-oriented, organized, and able to meet deadlines.
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