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Overview:
- 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.