Global CMC Regulatory Science Lead – International

Moderna Therapeutics; Greater London; On-site; GBP 110,000 - 150,000; Full time

Benefits offered by this job

Best-in-class healthcare

Family building benefits

Generous paid time off

Job summary

Moderna Therapeutics is seeking an Associate Director, CMC Regulatory Science-International based at the UK site. You will develop regulatory strategies, oversee submissions, and guide cross-functional teams on CMC matters for global programs, including vaccines and oncology.

The role requires leading interactions with regulatory authorities and managing multiple projects in a fast-paced environment. You will bring 10+ years in pharma/biotech with biologics CMC experience, and an MS/PhD in a

Qualifications

• 10+ years of experience in the pharmaceutical/biotech industry with regulatory CMC focus.
• 8+ years of biologics-focused regulatory CMC experience.
• Strong knowledge of EU and ROW regulations and CTD format.

Responsibilities

• Develop/implement effective CMC regulatory strategies for global submissions (IND/CTA/MAA/BLAs).
• Provide guidance for regulatory CMC aspects of product development projects.
• Review documents for submission-readiness to ensure adherence to guidelines.
• Drive regulatory CMC discussions with health authorities to facilitate approvals.
• Lead oversight of multiple programs across vaccines, oncology and/or rare diseases.

Skills

CMC regulatory strategy

Regulatory submissions

Cross-functional leadership

Regulatory compliance

Project management

Education

MS/PhD in Molecular Biology or related field

Job description

Moderna Therapeutics is seeking an Associate Director, CMC Regulatory Science-International based at the UK site. You will develop regulatory strategies, oversee submissions, and guide cross-functional teams on CMC matters for global programs, including vaccines and oncology.

The role requires leading interactions with regulatory authorities and managing multiple projects in a fast-paced environment. You will bring 10+ years in pharma/biotech with biologics CMC experience, and an MS/PhD in a