UK CMC Regulatory Strategy Lead

Moderna Therapeutics

Greater London

On-site

GBP 150,000 - 190,000

Full time

4 days ago

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Benefits offered by this job

Healthcare

Well-being resources

Family benefits

Paid time off

Savings & investments

Location perks

Job summary

Moderna Therapeutics in London is seeking a senior Regulatory CMC leader to shape UK CMC strategies for mRNA products from development through commercialization. You will collaborate across Technical Development, Manufacturing, Quality, Clinical and Regulatory teams, guiding submissions and lifecycle management with MHRA engagement.

The role requires deep regulatory science expertise, strategic judgment, and experience navigating UK and international CMC requirements to enable timely product

Qualifications

BS/MS/PhD in relevant field required.
8+ years in pharma/biotech manufacturing or analytics.
Experience leading UK CMC regulatory submissions (CTD) preferred.
Strong knowledge of UK MHRA and global CMC requirements.

Responsibilities

Define and lead UK CMC regulatory strategy for UK products across lifecycle.
Provide leadership for submissions, ensuring robustness and alignment.
Assess manufacturing/quality changes for regulatory impact.
Engage MHRA and international health authorities in scientific discussions.
Translate evolving UK CMC guidance into actionable plans for programs.

Skills

Cross-functional leadership

Independent judgment

Regulatory communication

Global CMC strategy

Influence without authority

Regulatory policy interpretation

Education

BSc/MSc/PhD in Molecular Biology/Pharmaceutics/Chemistry/Chemical Engineering or related

Job description

The role requires deep regulatory science expertise, strategic judgment, and experience navigating UK and international CMC requirements to enable timely product

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