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Executive/ive - Regulatory Affairs (Canada Market)

2 weeks ago

Bengaluru, Karnataka, India Strides Pharma Science Full time ₹ 8,00,000 - ₹ 12,00,000 per year
  • Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Canada market for CMC and labelling aspects.
  • Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines.
  • Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities
  • Co-ordinate with cross functional teams for document request, review, required for regulatory submission
  • Upload and publish the documents in eCTD software required for regulatory submission
  • Arranging and coordinating trainings within departments