Title: VP Global Regulatory Affairs
Summary: A world leader in the radiopharmaceutical industry is seeking a Regulatory Affairs expert to join their team. Acting as the global leader of the Regulatory function, this professional will develop and implement RA strategy in the life-cycle of both development stage and marketed products. This global leader will provide regulatory oversight for all programs, serving as the chief spokesperson for Regulatory agencies. The right professional is a passionate expert in Regulatory Affairs with extensive leadership experience and in-depth knowledge of oncology drug development. This position reports directly into the CMO.
The VP, Global Regulatory Affairs is responsible for:
- Establishing and implementing Regulatory Strategy for global regulatory submissions across marketed and development stage products.
- Act as the company representative for Regulatory Agencies, keeping up to date on industry requirements and procedures. Utilize in depth understanding of regulatory affairs and oncology to ensure high quality, successful submissions globally.
- Creating an innovative and effective vision for the Regulatory and Pharmacovigilance function, identifying key areas for growth and success. Mentoring, leading, and expanding the Regulatory team to create a cohesive team environment in line with company values.
- Oversee management of global CRO partner and lead training and performance of contract staff.
- Collaborate with Senior Leadership and External Partners for overall company strategic and operating plans as a key member on the CMO Leadership team.
The VP, Global Regulatory Affairs should have the following qualifications:
- Bachelor's degree in science required, advanced degree preferred.
- 15+ years of direct Regulatory Affairs experience, with 5+ years of experience in a Regulatory leadership position.
- Global Regulatory Strategy experience, with in depth knowledge of oncology drug development. Experience with both marketed and development stage products
- Ability to lead both the Regulatory and Pharmacovigilance functions, with a passion for leading and mentoring junior professionals.
If you are interested in the VP, Global Regulatory Affairs role, then please don't wait to apply.