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.

Qualifications:

• 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