An up and coming Pharmaceutical company is currently seeking to hire a Global VP for their Regulatory Affairs department.
Key responsibilities of the Global VP RA include:
- Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan
- Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects
- Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products
- Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies
- Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible
- Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
Key requirements of the Global VP RA include:
- MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
- FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines
- Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
- CRO management experience preferred
- Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
- Must be a strong leader that creates a vision for group
- Demonstrates potential for a high level of collaboration with others and within global teams
- Fluent English, other languages beneficial#
- Eligibility to work in Switzerland
If you are interested in the Global VP position, send your CV or contact Sebastian Adams at +44 203 758 8792 for more information.
