Regulatory Affairs Manager

6 days ago


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

Job Summary:

The Regulatory Affairs Manager will be responsible for leading the End-to-End medical governance of regulated activities, in alignment with Medical Affairs strategy and priorities.

Key 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.

About Us:

We are a dynamic team at Healthcare Businesswomen's Association, and we're looking for a talented individual to join us as a Regulatory Affairs Manager. As a key member of our team, you will have the opportunity to work on exciting projects and contribute to the growth and success of our organization.



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