Regulatory Affairs Specialist

4 days ago


Klang, Selangor, Malaysia Healthcare Businesswomen's Association Full time

About the Role

As a key member of our team, you will be responsible for leading the end-to-end medical governance of regulated activities in alignment with Medical Affairs strategy and priorities. This includes acting as the country expert on MA processes, Novartis standards, and country regulation.

Main Responsibilities

  • Lead the End-to-End medical governance of regulated activities (Interventional and NIS/RWE, IIT, MAP, RC), in alignment with Medical Affairs strategy and priorities.
  • Act as the country expert on MA processes, Novartis standards, and country regulation.
  • Monitor adherence to Novartis processes, standards, and country regulations.
  • Support data quality/integrity in country MA.
  • Coordinate processes for medical information services, aligning CPO needs with Novartis requirements, including appropriate handling of potential adverse event and product complaint reporting.

What We Offer

  • Professional development opportunities
  • A dynamic and supportive work environment
  • The chance to make a meaningful contribution to our organization


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