Senior Regulatory Portfolio Manager

2 weeks ago


Portishead, North Somerset, United Kingdom CK Group Full time
Senior Regulatory Portfolio Manager

CK Group is seeking a highly skilled Senior Regulatory Portfolio Manager to join a global pharmaceutical company on a contract basis for 8 months. This is a remote role.

Key Responsibilities:
  • Collaborate with Regulatory Leads and the Global Regulatory Sub-Team to develop and execute the optimal regulatory strategy for assigned assets.
  • Partner with the Global Regulatory Lead and the Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets.
  • Support and coordinate preparations for FDA meetings.
  • Track key regulatory milestones, including health authority meetings, post-approval commitments, annual reports, and other critical deadlines.
  • Coordinate the rapid response process to ensure quality and timely responses to health authority queries globally.
  • Provide operational support to the Global Regulatory Lead on strategic global regulatory documents, including the Regulatory Strategy Plan.
Requirements:
  • Degree or equivalent in a healthcare-related field.
  • Direct regulatory experience with a 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 is strongly preferred.
About the 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. Their goal is to put patients first and help people around the world live better and healthier lives.

Location:

This is a 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.



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