Global Regulatory Strategy Director - Oncology & mRNA

Moderna; Cambridge (MA); Hybride; USD 225 000 - 405 000; Plein temps

Avantages offerts par ce poste

Competitive healthcare

Generous paid time off

Equity or incentive opportunities

Résumé du poste

Moderna is seeking a Senior Leader in Global Regulatory Strategy to define forward-looking regulatory plans for select oncology and therapeutic programs. You will partner with senior leaders across R&D, Clinical Development, CMC, Safety, Translational Medicine, and Commercial to accelerate development while ensuring rigorous regulatory compliance.

You will lead global Health Authority engagements, shape submission strategies, and mentor regulatory teams, while exploring Generative AI tools to

Qualifications

• Bachelor's degree in a scientific, medical, pharmaceutical, or related discipline required.
• 15+ years of progressive Regulatory Affairs experience with oncology programs.
• Experience leading global regulatory strategies and Health Authority negotiations.
• Experience mentoring regulatory professionals and leading cross-functional teams.

Responsabilités

• Define and drive integrated global regulatory strategies for oncology programs.
• Lead Health Authority interactions to align development plans and submission strategies.
• Mentor regulatory professionals and build organizational capabilities.
• Shape early development plans and evidence-generation requirements for pivotal programs.
• Incorporate innovative regulatory pathways and AI/digital tools into regulatory decision-making.

Connaissances

Strategic leadership

Regulatory strategy

Global regulatory affairs

Oncology experience

Formation

Bachelor's in science (required)

Advanced degree (MS/PhD/MD/PharmD) preferred

Outils

CTD/eCTD knowledge

Description du poste

Moderna is seeking a Senior Leader in Global Regulatory Strategy to define forward-looking regulatory plans for select oncology and therapeutic programs. You will partner with senior leaders across R&D, Clinical Development, CMC, Safety, Translational Medicine, and Commercial to accelerate development while ensuring rigorous regulatory compliance.

You will lead global Health Authority engagements, shape submission strategies, and mentor regulatory teams, while exploring Generative AI tools to