Associate Director, Global CMC Regulatory Strategy

Moderna; England; On-site; GBP 120,000 - 150,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family building benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking an experienced Associate Director for Global Regulatory Science, CMC, to lead regulatory activities and develop CMC strategies for international submissions. You will guide product development projects and oversee critical regulatory documentation to enable transforms in patient care.

The role requires extensive experience in regulatory CMC, especially for biologics, and strong cross-functional collaboration with manufacturing and QA teams.

Qualifications

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required.
• MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable.
• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 8+ years of experience in Biologics focused Regulatory CMC.
• Multidisciplinary focus in vaccines, oncology and/or rare diseases.
• Strong knowledge of current EU and ROW regulations.
• Strong knowledge of Cgmp.
• Strong experience with CTD format and content regulatory filings.
• Exceptional written and oral communication.
• Enhanced pre-employment checks may be required.

Responsibilities

• Develop and implement effective CMC regulatory strategies for international submissions.
• Review documents for submission-readiness per health authority guidelines.
• Provide regulatory guidance to manufacturing and quality teams.
• Lead regulatory CMC discussions with health authorities.
• Enhance regulatory processes supporting CMC components.
• Support creation and maintenance of CMC submission templates.
• Provide regulatory guidance for various therapeutic areas.
• Oversee multiple programs and assess CMC change controls.
• Lead and support all regulatory activities delivering high-quality CMC documentation.

Skills

Regulatory strategy

Regulatory CMC

EU & ROW regulations

CGMP knowledge

CTD filings

Regulatory communications

Pre-employment checks

Education

BS in Pharmaceutics/Chemistry/Engineering

MS in Pharmaceutics/Chemistry/Engineering (desirable)

Tools

Job description

Moderna is seeking an experienced Associate Director for Global Regulatory Science, CMC, to lead regulatory activities and develop CMC strategies for international submissions. You will guide product development projects and oversee critical regulatory documentation to enable transforms in patient care.

The role requires extensive experience in regulatory CMC, especially for biologics, and strong cross-functional collaboration with manufacturing and QA teams.