Associate Director Regulatory Affairs
My client is only a handful of companies with potential first line treatment for patients who suffer from rare, yet serious forms of cancer. They are looking for an Associate Director to lead the company’s Ph. II through registration filing for a novel immunotherapy treatment. You will have the opportunity to potentially put a successful filing under your belt within the next year. This is your opportunity to join a devoted team in support of potential top-line results for oncology patients world-wide.
Responsibilities:
- Develop and implement innovative regulatory strategies in support of global development, registration and life-cycle management of assigned programs
- Advise teams and management on the impact of regulatory climate and changing regulations pertaining to research and development programs and commercial operations
- Develop and implement strategies for the most efficient, timely submission and approval of regulatory filings from clinical trial applications through Phase 4
- Drive decision-making in the cross-functional teams with respect to regulatory issues
Knowledge and Skills:
- Minimum BS in a scientific discipline; advanced degree preferred
- At least 5 years of pharmaceutical industry experience in regulatory affairs
- Must have working knowledge of U.S. and international drug and biologic guidelines and regulations
- Early development regulatory experience
- Direct experience working with FDA required; international experience a plus
- Experience in oncology product development