Senior Director Regulatory Affairs (Oncology)
Company Summary:
My client, a leader in the biotechnology industry, focused on a new generation of compounds to help treat a variety of metabolic, oncological, and psychiatric diseases. They are experiencing a lot of growth, having added about 100 employees over the last year to their team of about 400. My client is located in Menlo Park, CA and is seeking a hybrid (3 days per week) Regulatory Affairs Senior Director!
The Regulatory Affairs Senior Director will be responsible for:
- Developing global regulatory plans to help progress programs in all phases of development
- Managing submissions/regulatory documents supporting IND, CTA, and marketing applications
- Preparing for/attending meetings with FDA and ex-US regulatory agencies
- Monitoring changed in global rules and regulations governing drugs and biologics in all phases of development
- Identifying risk mitigation strategies and influencing project teams to increase likelihood of regulatory success
The Regulatory Affairs Senior Director should have the following qualifications:
- 10+ years of Regulatory Affairs experience in the biotechnology/pharmaceutical industries
- Experience preparing global regulatory submissions including INDs, CTAs, marketing applications, and meeting briefing packages
- Scientific background in oncology, endocrinology, neurology is desirable
- Management experience and the ability to develop a team
