Associate Director, Regulatory Affairs

Responsibilities

• Lead one or more drug development programs with a focus on global (Ex-US) regulatory strategy and submissions
• Interact with global regulatory authorities including Health Canada, MHRA, EMA, Swiss Medic, and TGA
• Collaborate with functional leaders to create and execute optimal clinical-regulatory development paths
• Manage the creation of Clinical Trial Applications, Market Applications, and amendments
• Lead cross-functional teams in developing strategic briefing packages for health authority meetings
• Incorporate evolving global regulations and guidelines for biologics and ATMPs into program decision making

Requirements

• BS degree in life sciences (Advanced degree preferred)
• Minimum 5 years of regulatory affairs experience with an advanced degree, or 7 years with a BS
• Late-stage experience in oncology drug development
• Proven experience negotiating clinical-regulatory aspects of oncology programs with Ex-US health authorities
• Ability to write and edit high-quality documents such as briefing books, investigator brochures, and clinical study reports

Preferred Qualifications

• Advanced degree (MS, PharmD, PhD)
• 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, harnessing the human immune system to attack diverse cancer cells.