Regulatory Affairs Specialist

1 week ago


Kuala Lumpur, Kuala Lumpur, Malaysia People Profilers Full time

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at People Profilers. As a Regulatory Affairs Specialist, you will be responsible for supporting Regional Regulatory Leads in creating regulatory strategies for assigned pipeline products in Asia.

You will provide documentation to country RA leads as required to drive their new NDA and life-cycle management submissions. Additionally, you will coordinate submission requirements between country RA leads and other teams as applicable.

This role requires a strong understanding of the medicinal and/or medical device legislation and guidelines of the Asia region relevant for the scope of products/projects.

Responsibilities
  • Support Regional Regulatory Leads in creating regulatory strategies for assigned pipeline products in Asia.
  • Provide documentation to country RA leads as required to drive their new NDA and life-cycle management submissions.
  • Coordinate submission requirements between country RA leads and other teams as applicable.


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