Summary of Position

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.

Essential Functions

Primary Responsibilities

Global Regulatory Strategy

• 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 preferred
• Bachelor's degree in life sciences required

Experience required

• 10+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry in oncology drug development
• Demonstrated experience as global regulatory lead, leading global regulatory strategy as part of cross functional program team
• Experience spanning early clinical through product registration
• Experience leading FDA and international Health Authority interactions
• Experience leading major global regulatory submissions

Preferred :

• Radiopharmaceutical or nuclear medicine therapeutic experience
• Targeted radionuclide therapy experience
• Companion diagnostic experience
• Combination product experience

Ideal Candidate Profile

The ideal candidate combines deep regulatory expertise with oncology development experience and has successfully led programs from IND/CTA through NDA/BLA or MAA approval. They are comfortable navigating the unique scientific and regulatory challenges associated with targeted radiopharmaceuticals, including dosimetry, isotope manufacturing, companion diagnostics, and accelerated development pathways. They are recognized as a strategic partner capable of influencing senior leadership while effectively collaborating across global, multidisciplinary teams.

Competencies

ANALYZE + ADAPT

COMMUNICATE EFFECTIVELY

DEVELOP SELF + OTHERS

INTERNAL/EXTERNAL CUSTOMER-FOCUSED

RESULTS-DRIVEN