Title: Director/Senior Director of Regulatory
Summary:
An Oncology based biotech client of ours is looking to fill their Director/Senior Director role based out of their facility in the San Francisco Bay Area. They are looking for very committed and passionate candidates who can collaborate with their colleagues to help build this exciting company. This role will give you the opportunity to help in their mission to discover and develop the most innovative oncology-based therapies.
The Director/Senior Director will be responsible for…
- Developing and executing regulatory strategies aimed at securing and sustaining clinical trial applications
- Taking the lead on preparing FDA Submissions, specifically INDs
- Serving as point of contact with FDA; liaise and negotiate all FDA interactions
- Providing mentorship and guidance to multidisciplinary teams
The Director/Senior Director should have the following qualifications:
- Bachelor's degree in chemistry, biochemistry, pharmacy, pharmacology, or related discipline; master's or PhD preferred
- 10+ years within pharmaceutical or biotechnology industry; 7+ years focused in regulatory affairs
- Radio Expertise
- Prior experience working with FDA submissions, specifically IND
