- Life Science
- Medical Device
Associate Director / Director, Regulatory Affairs
Our client, a progressive biopharmaceutical company, has a new opportunity for an
Associate Director / Director, Regulatory Affairs professional with clinical expertise in the San Francisco Bay area. This is a full-time, onsite position with a primary focus on the discovery and development of oncology drugs.
- Lead regulatory document preparation including briefing books and liaise with global regulatory authorities
- In a team environment, aid in creating regulatory strategy for pipeline
- Previous IND/NDA/MAA submission expertise
- Collaborate with other departments to ensure execution of regulatory strategy and to define corporate goals.
- BS Degree Required, PhD or PharmD Preferred
- 7+ years of experience in the pharmaceutical industry with roles in Regulatory Affairs
- Oncology experience highly desired
- Solid successful IND and NDA submission expertise along with positive FDA/Regulatory Agency relationships is required
- Excellent written and verbal communication skills
- Experience in a global company, with understanding of international regulatory environments is a plus
- A demonstrated career of high performance in a small company environment is highly desired