Lead CMC Regulatory Strategy – UK & Global

Moderna; Harwell; On-site; GBP 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid working model

Competitive healthcare

Well-being and fitness resources

Family building benefits

Generous paid time off and sabbatical

Job summary

Moderna seeks a senior Regulatory CMC leader to shape UK regulatory strategies for UK-produced and UK-licensed mRNA products. The role spans development through commercialization and post‑approval lifecycle, collaborating with MHRA and global teams.

You will drive submissions, evaluate manufacturing/quality changes, and mentor teams to ensure compliant, timely product milestones in a dynamic, high-growth environment.

Qualifications

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• 8+ years in pharmaceutical/biotech manufacturing or analytics.
• 5+ years in Biologics-focused Regulatory CMC.
• Strong knowledge of UK CMC regulations and CTD format.

Responsibilities

• Define and lead UK CMC regulatory strategy for UK-manufactured and UK-licensed products.
• Lead preparation and management of CMC/Quality regulatory submissions.
• Provide expert regulatory assessment of manufacturing and quality changes.
• Engage MHRA and other health authorities in regulatory discussions and meetings.
• Monitor UK CMC regulations and translate guidance into strategy.
• Establish regulatory compliance frameworks for lifecycle management.
• Lead cross-functional strategy across Technical Development, Manufacturing, Quality, Clinical, and Regulatory teams.

Skills

Regulatory CMC strategy

Regulatory leadership

Cross-functional collaboration

Strategic judgement

MHRA submissions

Education

BS/MS/PhD in Molecular Biology/Pharmaceutics/Chemistry or related field

Job description

Moderna seeks a senior Regulatory CMC leader to shape UK regulatory strategies for UK-produced and UK-licensed mRNA products. The role spans development through commercialization and post‑approval lifecycle, collaborating with MHRA and global teams.

You will drive submissions, evaluate manufacturing/quality changes, and mentor teams to ensure compliant, timely product milestones in a dynamic, high-growth environment.