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Overview:
- Iovance seeks a highly motivated Senior Regulatory Affairs Specialist to support clinical programs and regulatory submissions.
- The role involves planning and managing submissions to FDA and other global health authorities.
Key Responsibilities:
- Manage IND/CTA amendments, annual reports, DSURs, and investigator packages.
- Independently oversee submission planning and vendor management for high-quality deliverables.
- Represent Regulatory Affairs on cross-functional teams and maintain submission trackers.
Qualifications:
- BS degree required; advanced degree preferred (PharmD, PhD, Master’s).
- Minimum 8 years of regulatory affairs experience in drug/biologic development.
- Strong understanding of US and ex-US regulations, with eCTD experience preferred.
Iovance Biotherapeutics
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.