Head of Global Regulatory Affairs
My client is one of the largest vaccine companies in the world and has retained us to fill a newly created Head of Global Regulatory Affairs position. In this highly visible opportunity you will be responsible for growing both the US and Global regulatory teams while being the primary contact for agency interaction. This is a unique opportunity for you join a stable global company and be a part their collaborative, science driven culture.
Responsibilities:
- Establish relationship with CBER
- Develop and hire a regulatory department
- Actively contribute to the global regulatory community through designated projects
- Provide strategic leadership of the company’s product development and registration projects to meet the global business objectives for the region
- Establish regulatory procedures and strategy
- Establish and maintain a relationship with the FDA
- Provide a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed
Knowledge and Skills:
- A degree in Biological or Medical Science or Pharmacy, preferably with a post graduate qualification
- At least 10 years of regulatory experience, supported by additional pharmaceutical/industry experience
- CBER experience required
- Biologics experience also a must
- Experience managing direct reports and teams
- Vaccine experience a plus