CMC Regulatory Science Lead – Global Submissions

Moderna; Harwell; Sur place; GBP 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Best-in-class healthcare

Well-being resources

Family building benefits

Generous paid time off

Savings and investments

Location-specific perks and extras

Résumé du poste

Moderna is seeking an Associate Director, CMC Regulatory Science-International based in Harwell, UK. You will oversee regulatory CMC strategy, submissions, and compliance for mRNA products, coordinating with manufacturing, quality, and analyticalDevelopment teams on global filings.

Key responsibilities include guiding regulatory CMC aspects, ensuring submission readiness, and managing multiple complex programs across therapeutic areas in a fast-paced environment.

Qualifications

• MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field.
• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus.
• 8+ years of experience in Biologics focused Regulatory CMC.

Responsabilités

• Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for regulatory CMC aspects of product development projects
• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines
• Drive Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
• Support the development of regulatory processes and procedures to support CMC components of regulatory submissions
• Support the creation and maintenance of CMC submission templates

Connaissances

CMC regulatory strategy

Regulatory submissions

Cross-functional collaboration

Formation

MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

Outils

CTD format knowledge

Regulatory filings

Description du poste

Moderna is seeking an Associate Director, CMC Regulatory Science-International based in Harwell, UK. You will oversee regulatory CMC strategy, submissions, and compliance for mRNA products, coordinating with manufacturing, quality, and analyticalDevelopment teams on global filings.

Key responsibilities include guiding regulatory CMC aspects, ensuring submission readiness, and managing multiple complex programs across therapeutic areas in a fast-paced environment.