A 100% Remote Director/Associate Director of Regulatory Affairs role is now open.
This position will work to build and execute regulatory strategy for our biologics and endocannabinoid programs. They will be responsible for regulatory submissions in support of our biologic assets in immune oncology. This person will be a crucial member of cross-functional teams and work with subject matter specialists to establish development and regulatory strategy.
Key Duties:
- Serve as regulatory head on development study teams as well as supporting sub-teams
- Create effective regulatory strategies and ensure regulatory compliance within clinical and preclinical activities
- Work together with regulatory and cross-functional colleagues on clinical document preparation and evaluations
- Lead negotiations with regulatory organizations to take on issues and coordinate preparation and submission of responses to various Health Agency's questions
- Preparation and submission of regulatory filings
Knowledge and Skills:
- BS/BA in biochemistry, chemistry, biology or related life/health sciences is required. Advanced degree (MD, PhD, PharmD, MS) is a plus
- Min. 10-years of regulatory experience in a biotech/pharma company as a strategist
- Candidate is expected to be well versed in the regulatory needs of clinical / preclinical development of biopharmaceuticals and have excellent project management skills, as well as a good understanding of the underlying science.