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Key Responsibilities:
- Lead global regulatory strategy for one or more drug development programs, with emphasis on Ex-US health authorities.
- Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments.
- Ensure submission documents are of the highest quality and incorporate evolving regulations.
Qualifications:
- BS degree in life sciences required; advanced degree preferred.
- Minimum 5 years' experience in regulatory affairs with late-stage oncology drug development.
- Proven ability to write and edit high-quality clinical-regulatory documents.
Work Environment:
- This role operates in a professional or remote office environment.
- Must be able to remain stationary for prolonged periods and use standard office equipment.
- Requires excellent judgment, problem-solving, and ability to manage multiple priorities.
Iovance Biotherapeutics
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.