The Associate Director of Regulatory Affairs (Strategy) will help assist in strategic and operations regulatory functions including Clinical, Non-clinical, and CMC.
- Create effective regulatory strategies and ensure regulatory compliance
- 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
- Identify and prose risk mitigation strategies
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. 7-years of regulatory experience in a biotech/pharma
- The candidate is expected to be well versed in the regulatory needs of clinical/preclinical development of biopharmaceuticals and has excellent project management skills, as well as a good understanding of the underlying science.
- Oncology experience (preferred)
If interested in the Director Regulatory Affairs Strategy, don't hesitate apply now!