Associate Director, Global CMC Regulatory Strategy

Moderna Therapeutics Inc.; Greater London; Hybride; GBP 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Healthcare benefits

Paid time off

Résumé du poste

Moderna Therapeutics Inc. is seeking an Associate Director, Global Regulatory Science, CMC in London to shape global CMC regulatory strategy across an innovative mRNA portfolio.

You will lead regulatory submissions, guide cross-functional teams, and drive compliance with EU and ROW requirements. The role emphasizes collaboration with Manufacturing, Quality, and development teams, and involves interactions with health authorities to accelerate access to transformative medicines.

Qualifications

• 10+ years in pharmaceutical/biotech with manufacturing or analytical focus.
• 8+ years in biologics-focused Regulatory CMC.
• Strong knowledge of EU and ROW regulations and CGMP.

Responsabilités

• Develop and implement global CMC regulatory strategies for international submissions.
• Lead and support CMC activities across product development timelines.
• Prepare, review, and deliver high-quality CMC sections for regulatory submissions.
• Provide CMC regulatory guidance to Manufacturing, Quality, and cross-functional teams.
• Lead CMC regulatory discussions with global health authorities.
• Improve regulatory processes and submission templates for efficiency.
• Offer strategic CMC guidance across multiple therapeutic areas.
• Oversee multiple development programs and assess regulatory impact of changes.
• Collaborate with cross-functional teams to ensure alignment with development plans and compliance.

Connaissances

Regulatory CMC

Global regulatory strategy

CTD/Regulatory submissions

Cross-functional collaboration

Regulatory writing

Effective communication

Formation

BS in Pharmaceutics/ Chemistry/ Chemical Engineering

MS degree desirable

Description du poste

Moderna Therapeutics Inc. is seeking an Associate Director, Global Regulatory Science, CMC in London to shape global CMC regulatory strategy across an innovative mRNA portfolio.

You will lead regulatory submissions, guide cross-functional teams, and drive compliance with EU and ROW requirements. The role emphasizes collaboration with Manufacturing, Quality, and development teams, and involves interactions with health authorities to accelerate access to transformative medicines.