Global CMC Regulatory Strategy Director

Moderna Therapeutics; Greater London; Hybrid; GBP 80,000 - 120,000; Full time

Benefits offered by this job

Best-in-class healthcare

Generous paid time off

Holistic approach to well-being

Job summary

Moderna Therapeutics is seeking an Associate Director for Global Regulatory Science, CMC in London, England. This pivotal role involves leading regulatory activities, developing CMC strategies for international submissions, and overseeing critical regulatory documentation.

The ideal candidate will have over 10 years of experience in the pharmaceutical/biotech industry and 8 years focused on Biologics regulatory CMC. Attractive benefits and a dynamic workplace are offered.

Qualifications

• 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 on therapeutic areas such as vaccines, oncology and/or rare diseases.

Responsibilities

• Develop and implement effective CMC regulatory strategies for international submissions.
• Lead regulatory CMC discussions and interactions with health authorities.
• Oversee multiple programs, evaluating CMC change controls and their impact on internal programs.

Skills

Strong knowledge of current EU and ROW regulations

Strong experience with CTD format and content regulatory filings

Exceptional written and oral communication

Education

BS in Pharmaceutics, Chemistry, Chemical Engineering or closely related field

MS degree in Pharmaceutics, Chemistry, Chemical Engineering or closely related field

Tools

Understanding of Cgmp

Job description

Moderna Therapeutics is seeking an Associate Director for Global Regulatory Science, CMC in London, England. This pivotal role involves leading regulatory activities, developing CMC strategies for international submissions, and overseeing critical regulatory documentation.

The ideal candidate will have over 10 years of experience in the pharmaceutical/biotech industry and 8 years focused on Biologics regulatory CMC. Attractive benefits and a dynamic workplace are offered.