Global Regulatory Strategy Director - Oncology

Moderna Inc.; Cambridge (MA); On-site; USD 225,000 - 405,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being programs

Family planning benefits

Generous paid time off

Job summary

Moderna Inc. is seeking a senior Global Regulatory Lead to define forward-looking regulatory strategies for select oncology programs.

You will collaborate with senior leaders across functions to accelerate development, guide evidence-generation, and shape pathways to registration. You will partner with cross-functional teams, influence senior leadership, and drive regulatory strategies for complex modalities including mRNA-based therapies.

Qualifications

• Bachelor’s degree in scientific, medical, pharmaceutical, or related discipline required; advanced degree preferred.
• 15+ years of progressive Regulatory Affairs experience, including leadership of global regulatory strategies for oncology programs.
• Experience leading global regulatory interactions and negotiations with Health Authorities.
• Experience mentoring/regulating professionals and guiding regulatory capabilities.

Responsibilities

• Provide senior strategic leadership for global regulatory strategies supporting oncology programs.
• Lead health authority engagement strategies with FDA, EMA, and other agencies.
• Shape early development plans, regulatory milestones, and evidence-generation requirements.
• Champion innovative regulatory pathways and accelerated development strategies.
• Mentor regulatory professionals and strengthen capabilities across Moderna.

Skills

Oncology drug development

Global regulatory lead

Mentoring regulatory professionals

Strategic thinking & negotiation

Education

Bachelor's degree in science/medical/pharma

Advanced degree (MS/PhD/PharmD/MD)

Job description

Moderna Inc. is seeking a senior Global Regulatory Lead to define forward-looking regulatory strategies for select oncology programs.

You will collaborate with senior leaders across functions to accelerate development, guide evidence-generation, and shape pathways to registration. You will partner with cross-functional teams, influence senior leadership, and drive regulatory strategies for complex modalities including mRNA-based therapies.