Associate Director, Regulatory Affairs (Fully Remote)

Responsibilities: Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments. Lead cross-functional teams in preparing briefing packages and health authority meetings. Ensure evolving regulations for biologics and cell therapy are incorporated into decisions.

Qualifications: BS in life sciences with 10+ years regulatory experience; advanced degree preferred. Late-stage oncology drug development experience and strong writing skills required. Iovance Biotherapeutics Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.