Senior Regulatory Affairs Specialist

2 weeks ago


Chennai, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 28,00,000
  • Key Responsibilities:
  • Prepare, review and submit amendments and supplements for the assigned products.
  • Compile summary documents for regulatory submission.
  • Respond to agency queries in a timely manner.
  • Submit Global Annual Reports on time.
  • Review stability protocols and reports for analytical method validation.
  • Examine raw material, packaging material and finished product specifications.
  • Verify batch records for accuracy.
  • Review Process Validation Protocol and hold time study protocols.
  • Additional Tasks:
  • Review Product Development Report.
  • Verify executed documents including Certificate of Analysis for compliance with regulatory requirements.


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