Senior Regulatory Portfolio Manager
3 months ago
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.
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