Executive - Regulatory Affairs

15 hours ago

Delhi, Delhi, India Polymed Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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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