One of the top 20 pharmaceutical companies is now looking for an experienced Global Regulatory Lead to join their growing team and support their regulatory structure. After the recent acquisition of a biotechnology company, the business is undergoing an exciting transformation and the right candidate will have the chance to be a main player in cross-functional liaison with several key business units.
Key Responsibilities
- Integrating global regulations with legal, medical and scientific perspectives to produce successful outcomes in line with company's goals.
- Organising and liaising with partners, and representing projects globally in committees and meetings.
- Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may impact on the company
Requirements
- Minimum of 7 years' experience within a senior regulatory position
- Understanding of global regulatory principles and their impact on company's development and business
- MAA/NDA/BLA, CTA/IND, Device File, Site Master File, PIP/PSP including modifications, commitments, pharmacovigilance documents (DSUR, PSUR, RMP), renewals, post approval changes, meeting request and meeting packages
- Experience in biologics, bioprocess or cardiovascular
- 50% home based role.
On offer are a competitive salary package, unrivalled career progression opportunities and a chance to work with some of the most innovative products on the market to date. Don't hesitate to apply if you are looking for your next challenge!
