Senior Vice President Regulatory Affairs
Unlike other biopharma companies, my client is constantly expanding their pipeline and launching new business units, allowing employees to experience the full life cycle of a company. They are positioned to lead the charge related to many of today’s most debilitating diseases and illnesses. In this newly created Senior Vice President role, you will have the opportunity to oversee all regulatory strategy in support of several companies under their umbrella. This is a great chance to join this no fear, up-for-a challenge company culture!
Responsibilities:
- Develop and execute governance level regulatory strategy and plans in support of corporate goals and objectives within our central location
- Develop and direct the execution of the company’s ongoing regulatory strategy in support of the approved team’s target product profile
- Review new product opportunities and provide regulatory guidance and opinion
- Ensure that only high quality regulatory submissions are submitted to competent authorities
- Direct the IND, NDA, and BLA (and global equivalent) processes and communicate strategy with regulatory authorities
- Include key interactions or dependencies with other jobs, functional areas and/or external service provider
Knowledge and Skills:
- Bachelor’s level degree required, advanced degree strongly preferred
- 15 years’ industry experience with a minimum of 12 years spent in a regulatory capacity.
- Proven management and leadership experience, including developing talent
- Strong track record of leading face to face meetings with regulatory authorities
- Experience in multiple therapeutic areas; Neurology, Oncology, Orphan Drug therapeutic area experience is highly desirable
- Demonstrated success in high level management positions in Regulatory Affairs departments in pharmaceutical/biopharmaceutical companies