Senior Regulatory Affairs Specialist

7 hours, 41 minutes ago
Full-time
Senior
Operations
Iovance Biotherapeutics

Iovance Biotherapeutics

Iovance Biotherapeutics is a biopharmaceutical company pioneering TIL therapy to treat cancer by utilizing the patient's immune system to target cancer cells.

Pharmaceuticals
251-1K
Founded 2007

Description

  • Plan and oversee IND-related regulatory activities, including annual reports, orphan drug reports, DSURs, and CTA work for ongoing studies and study start-ups.
  • Manage the planning, compilation, quality control, and submission of INDs, BLAs, and related amendments.
  • Prepare routine regulatory documents such as Annual Reports, DSURs, Investigator Packages, and SUSARs.
  • Manage vendors and CROs to track source documents and deliver high-quality submissions on time.
  • Support regulatory strategy implementation across programs from IND through NDA/BLA approval and commercialization.
  • Work with submission authors and reviewers to ensure documents are complete, accurate, consistent, and compliant with regulatory guidelines and company standards.
  • Represent Regulatory Affairs on cross-functional teams and provide regulatory expertise on assigned projects and topics.
  • Maintain submission trackers, IND/CTA logs, and correspondence records with FDA and other regulatory agencies.
  • Prepare templates, shells, and presentations for internal and external audiences.
  • Manage multiple products and submissions with limited supervision.

Requirements

  • Bachelor’s degree required; advanced degree such as PharmD, PhD, or Master’s preferred.
  • Strong scientific or research background in pharmacy, chemistry, biology, or related experience preferred.
  • 8+ years of experience in regulatory affairs or a related role in drug/biologic development.
  • Experience managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format is a plus.
  • Understanding of U.S. and ex-U.S. drug/biologics regulations, including ICH and regional requirements.
  • Advanced proficiency with Microsoft Word, PowerPoint, Excel, and Adobe Acrobat Pro.
  • High attention to detail and accuracy.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to work independently with minimal supervision and adjust to changing priorities in a fast-paced environment.
  • Experience engaging both in-person and remote team members is preferred.

Benefits

  • Remote work environment (#LI-Remote).
  • Annual base salary of $140,000 to $160,000 USD.
  • Opportunity to work on innovative cancer cell therapy programs.
  • Opportunity to support work from IND through NDA/BLA approval and commercialization.
  • Commitment to a diverse and inclusive workplace.
  • Reasonable accommodations available upon request.

Interested in this position?

Apply directly on the company website

Apply Now

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