Executive Regulatory Affairs

5 days ago

Vadodara, Gujarat, India Exemed Full time ₹ 4,00,000 - ₹ 12,00,000 per year
  • Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.
  • Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.
  • To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.
  • Responsible for prepare and review Drug Master File as per respective reulatory agency guidline.
  • Responsible for ensuring that DMF submitting regulatory documentation, maintaning compliance and advising on regulatory strategies.
  • To ensure that Drug Master File (DMF) meet to current respective regulatory agency guideline.
  • Responsible for prepare Drug Master File (DMF) Deficiency response to respective regulatory agency.
  • Responsible for prepare Drug Master File (DMF) Amendment report to respective regulatory agency.
  • Responsible for prepare Drug Master File (DMF) Annual update report to respective regulatory agency.
  • Assessment and notification of change to regulatory agency and customer as per regulatory requirement.
  • Aim to serve as an internal API regulatory expert, ensuring regulatory compliance within the cross-functional teams.
  • Responsible for scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements including continuous improvement programs.

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