Director, Global Regulatory Lead

About the role

The Director, Global Regulatory Lead (GRL) will provide global regulatory leadership for one or more oncology programs focused on radiopharmaceutical/nuclear medicine therapeutics. This individual will develop and execute innovative global regulatory strategies supporting products from early clinical development through registration and lifecycle management.The successful candidate will serve as the Global Regulatory Lead for multidisciplinary development teams, partnering closely with Clinical Development, CMC, Nonclinical, Medical, Biostatistics, Quality, Biometrics, and Commercial to accelerate development while ensuring compliance with global regulatory requirements.The ideal candidate possesses extensive experience across both early- and late-stage drug development, including IND/CTA strategy, global Health Authority interactions, registration planning, and lifecycle management for oncology products. Experience with radiopharmaceuticals is strongly preferred.

Responsibilities

• Lead development and execution of global regulatory strategies for oncology programs.
• Serve as Global Regulatory Lead on cross-functional program teams.
• Develop comprehensive regulatory strategy and provide inputs to integrated program plans.
• Lead Global Regulatory Team and submission team accountable for delivering global program milestones.
• Develop regulatory pathways supporting development and commercialization.
• Identify regulatory risks and opportunities and recommend mitigation strategies.
• Lead meetings with health authorities, prepare briefing documents and lead cross-functional preparation for agency interactions.
• Ensure alignment of global regulatory strategy across US, EU, UK, Canada, Australia, Japan, and other key markets.
• Oversee the preparation and review of global regulatory submissions, including IND, CTAs, IND amendments, Annual reports, NDA/ BLA, etc.
• Monitor regulatory intelligence and Translate regulatory intelligence into actionable development strategies.

Requirements

• Education: PhD, PharmD, MD, MS, or equivalent scientific degree preferredBachelor’s degree in life sciences required
• Experience required: 10+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry in oncology drug developmentDemonstrated experience as global regulatory lead, leading global regulatory strategy as part