Senior Regulatory Portfolio Manager
2 months ago
Salary:
45.60 p/hPAYE.
Senior RegulatoryPortfolio ManagerRole:
- Partners withRegulatory Leads and wider Global Regulatory Sub-Team to deliverand execute the optimal regulatory strategy for assigned assets.The role reports directly to a Group Leader in Regulatory PortfolioManagement.
- Partner with the Global RegulatoryLead (GRL) and wider Global Regulatory Sub-Team (GRST) to deliverand execute the optimal regulatory strategy for assignedasset(s).
- Support and co-ordinate preparationsfor FDA meetings.
- Tracking key regulatorymilestones as defined by the GRST., health authority meetings,post-approval commitments, annual reports,etc.
- Co-ordinate the rapid response process toensure quality and timely responses to health authority queriesglobally.
- Provide operational support to theGRL on strategic global regulatory documents including theRegulatory Strategy Plan.
YourBackground:
- Degree orequivalent in healthcare related field.
- Directregulatory experience with developing knowledge of US and/or EUprocedures.
- Ability to work independently andat pace in a global matrix environment and effectivelyprioritize.
- Strong sense of personalaccountability for delivery; able to lead through influence andbuilding alignment with stakeholders to deliver projects toplan.
- Regulatory experience with a largepharmaceutical company strongly preferred.
Company:
Ourclient is the global leader in enabling pharma, biotech, andconsumer health partners to optimize product development, launch,and full life-cycle supply for patients around the world. They havethe goal of putting patients first and to help people around theworld live better and healthier lives.
Location:
Remoteposition.
Apply:
It isessential that applicants hold entitlement to work in the UK.Please quote job reference 107172 in allcorrespondence.
Pleasenote:
This role may be subjectto a satisfactory basic Disclosure and Barring Service (DBS)check.
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