Global Regulatory Lead
My client is an established mid-size global biopharma company with a presence in over 30 countries. They have partnered with us to fill a newly create Global Regulatory Lead position that has been created through innovation and growth. The hiring manager is seeking candidates who can skillfully architect the overall development blueprint and help other functional areas understand and provide solutions to what hurdles the team will encounter. This is a great opportunity for you to jump right into this established collaborative, science driven environment and hit the ground running!
Responsibilities:
- Take ownership and drive global regulatory strategy from the science
- Blaze new regulatory trails for rare disease
- Be responsible for regulatory strategic decision making necessary to ensure the planning and execution of successful global regulatory strategies, submissions and approvals for assigned project(s)
- Be accountable to lead the Global Regulatory Affairs Strategy Team for assigned projects to ensure alignment of the regional and CMC regulatory strategies with the global regulatory strategy
Knowledge and Skills:
- Minimum BS in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science required.
- MS/MBA, PhD, or MD preferred
- Minimum of 10 years’ experience in the biotech or pharmaceutical industry with at least 8 years in Regulatory (with 5+ years of that time in a commercial stage organization)
- Minimum 3-5 years’ experience leading and managing matrix teams
- Must have major market experience – FDA or EU global strategy
- Ability to drive strategy development hands on
- Must be a strong leader