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.