Associate Director, Regulatory Affairs

Responsibilities

• Lead drug development programs with emphasis on US and global regulatory strategy
• Manage Clinical Trial Applications, Market Applications, and amendments
• Collaborate with functional leaders to create optimal development paths for product candidates
• Lead cross-functional teams in developing strategic briefing packages for health authority meetings
• Ensure global regulations and guidelines for biologics or ATMPs are incorporated into decision making
• Ensure submission documents are of the highest quality in content, organization, and accuracy

Requirements

• BS degree in life sciences
• 10+ years of regulatory affairs experience (with BS), 8 years (with MS), or 5+ years (with PhD)
• Late-stage experience in oncology drug development
• Experience negotiating clinical-regulatory aspects with global health authorities
• Ability to write and edit high-quality clinical-regulatory documents like briefing books and protocols
• Strong organizational, planning, and multitasking skills
• Excellent interpersonal and communication skills

Preferred Qualifications

• Advanced degree (MS, MPH, PharmD, PhD)
• Experience in the creation, submission, and negotiation of market applications
• Experience with novel cell and gene therapy for oncology indications

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the human immune system.