Associate Director, Regulatory Affairs (Fully Remote)
iovance biotherapeuticsDenver, CO
Associate Director, Regulatory Affairs (Fully Remote)
iovance biotherapeuticsDenver, CO
yesterday
Industries
Research and Development in BiotechnologyBiological Product ManufacturingPharmaceutical Preparation ManufacturingAbout the role
Lead one or more drug development programs with focus on US and global regulatory strategy. Interact with regulatory authorities including Health Canada, MHRA, EMA, Swiss Medic, and TGA.
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.
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JOB OVERVIEW
Experience level
Manager
Location
Denver, CO
Occupation
Regulatory Affairs Managers
Industry
Research and Development in Biotechnology
Posted
yesterday
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