Executive Director, Regulatory Strategy

SUMMARY/JOB PURPOSE: The Executive Director, Regulatory Affairs has oversight for all regulatory activities for new development programs, pre-IND through BLA/NDA and post-approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Additionally, s/he provides expertise in translating regulatory requirements into practical, workable plans. Develops and implements strategies for earliest possible approvals of phase 1 through phase 4 applications. Provides counsel to and manages the clinical regulatory team. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies.…