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Senior Regulatory Portfolio Manager

2 months ago

Portishead, United Kingdom CK Group Full time
CK Group are recruiting for a Senior Regulatory Portfolio Manager, to join a global pharmaceutical company on a contract basis for 8 months. This is a remote role.



Salary:

45.60 p/h PAYE.

Senior Regulatory Portfolio Manager Role:
  • Partners with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets. The role reports directly to a Group Leader in Regulatory Portfolio Management.
  • Partner with the Global Regulatory Lead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliver and execute the optimal regulatory strategy for assigned asset(s).
  • Support and co-ordinate preparations for FDA meetings.
  • Tracking key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
  • Co-ordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
  • Provide operational support to the GRL on strategic global regulatory documents including the Regulatory Strategy Plan.

Your Background:
  • Degree or equivalent in healthcare related field.
  • Direct regulatory experience with developing knowledge of US and/or EU procedures.
  • Ability to work independently and at pace in a global matrix environment and effectively prioritize.
  • Strong sense of personal accountability for delivery; able to lead through influence and building alignment with stakeholders to deliver projects to plan.
  • Regulatory experience with a large pharmaceutical company strongly preferred.


Company:

Our client is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. They have the goal of putting patients first and to help people around the world live better and healthier lives.

Location:

Remote position.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 107172 in all correspondence.

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.