Director, Regulatory CMC

Responsibilities

• Lead drug development programs with an emphasis on global regulatory strategy and submissions
• Create optimal development paths for product candidates and negotiate with health authorities
• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments
• Lead cross-functional teams in preparing for health authority meetings
• Incorporate evolving global regulations and cell therapy guidelines into program decision making
• Ensure submission documents meet high standards of quality, organization, and accuracy

Requirements

• BS degree in life sciences
• Minimum 10 years of experience in regulatory affairs
• Late-stage experience in oncology drug development
• Experience creating and negotiating clinical-regulatory aspects of oncology programs
• Ability to write and edit high-quality clinical-regulatory documents (briefing books, protocols, CSRs)
• Strong organizational, planning, and multitasking skills
• Excellent interpersonal and communication skills

Preferred Qualifications

• Advanced degree (PhD, MS, or PharmD)
• Experience in the creation, submission, and negotiation of market applications

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.