Vice President, Regulatory Affairs Non-Clinical Responsibilities:
- Provide Leadership and oversight of the Non-Clinical Regulatory Affairs department.
- Provide regulatory strategy in design of non-clinical development programs and IND enabling studies.
- Determine overall regulatory strategy regarding early stage clinical protocol development.
- Work closely with cross functional teams to ensure development programs are aligned with clinical and commercial needs.
- Build a department to support an expanding pipeline of products in development and on the market.
- Work closely with other functions within Regulatory Affairs.
- Initiate and maintain effective partnerships with key functions (Toxicology, Pharmacology, Clinical Development).
- Develop and execute sound regulatory decisions and justifications.
- Provide direct supervision of individuals including mentoring, performance management and staffing decisions.
- Bachelor's degree or country equivalent. Higher degree will be an advantage; Minimum 20+ years in pharmaceutical industry, with increasing levels of expertise/experience.
- 15+ years of experience in Regulatory Affairs.
- International experience/exposure preferred.
- Proven regulatory leadership experience in a cross-functional role with significant product development experience.
- Established understanding of non-clinical development programs.
- Strong technical knowledge of non-clinical development.
- Strong knowledge and interest in the evolving landscape of novel clinical development programs.
- Experience with rare diseases preferable.
- Experience with breakthrough therapy designation products preferable.
- Experience leading transformational change within an organization is highly desirable.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.