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Senior Regulatory Portfolio Manager

CK Group- Science, Clinical and Technical
Posted 3 days ago, valid for 11 days
Location

Cambridge, Cambridgeshire CB21NT, England

Salary

£0 - £45.6 per hour

Contract type

Full Time

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Sonic Summary

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  • CK Group is seeking a Senior Regulatory Portfolio Manager for an 8-month remote contract with a global pharmaceutical company.
  • The role offers a salary of £45.60 per hour PAYE and requires direct regulatory experience, preferably with a large pharmaceutical company.
  • Key responsibilities include partnering with regulatory leads, supporting FDA meeting preparations, and tracking regulatory milestones.
  • Candidates should have a degree in a healthcare-related field and the ability to work independently in a global matrix environment.
  • Applicants must be entitled to work in the UK and may undergo a basic Disclosure and Barring Service check.
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 (phone number removed) in all correspondence.


Please note:

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

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By applying, a CV-Library account will be created for you. CV-Library's Terms & Conditions and Privacy Policy will apply.