Regulatory Affairs Global Therapeutic Lead
My client is an established mid-size global biopharma company with a presence in over 30 countries. We have been retained to fill a newly created Regulatory Affairs Global Therapeutic Lead position that has been created through innovation and growth. In this highly visible role you will be the principal in charge of my client’s premiere franchise while partnering with Senior Management and global teams to develop and execute the regulatory strategy. This is a great opportunity for you to jump right into this established collaborative, science driven environment and hit the ground running!
Responsibilities:
- Lead the global regulatory strategy for the franchise
- Blaze new regulatory trails for rare disease
- Develop and lead team
- Provide direction to Senior Leadership on emerging trends and strategies
- Ensure global regulatory strategies are updated for stage gate evaluations
- Provides global regulatory oversight for assigned therapeutic area(s), focused on pre-clinical and clinical aspects of drug development and associated regulations
Knowledge and Skills:
- Minimum BS in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science required.
- MS, PhD, MD, DVM preferred
- Minimum of 15 years’ experience in the biotech or pharmaceutical industry, with at least 9 years in Regulatory Affairs
- Minimum of 5 years’ experience in leading and managing teams, setting clear direction, holding people accountable and fostering a collaborative team environment
- More than one major market experience EU-US-Japan & agency
- Experience in working with global cross functional teams