Director, Global Regulatory Science, CMC

4 weeks ago


Norwood, Massachusetts, United States Moderna Full time
Job Title: Director, Global Regulatory Science, CMC

Moderna is seeking a highly experienced Director, Global Regulatory Science, CMC to lead our regulatory CMC activities for one or more products through all stages of a product's lifecycle. As a key member of our team, you will be responsible for developing and implementing effective CMC regulatory strategies for submissions, identifying regulatory risks, and providing guidance to product teams.

Key Responsibilities:
  • Develop and implement CMC regulatory strategies for submissions, including IND/CTA/BLA/MAA
  • Provide guidance to product teams on regulatory CMC aspects of product development projects
  • Review documents for submission-readiness to ensure compliance with health authority guidelines
  • Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Develop regulatory processes and procedures to support CMC components of regulatory submissions
  • Support the creation and maintenance of CMC submission templates
  • Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls
  • Perform assessment of manufacturing change controls
  • Provide interpretation of regulatory guidance documents, regulations, and directives to advise Manufacturing, Quality, and Process/Analytical Development groups
Requirements:
  • Bachelor's degree in a scientific/engineering discipline
  • 12+ years of experience in the pharmaceutical/biotech industry
  • 8+ years of experience in Regulatory CMC
  • Strong knowledge of current Global CMC regulations, including CTD format and content of CMC regulatory submissions
  • Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension, and license maintenance
  • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
  • Prior management experience required
  • Exceptional written and oral communication
About Moderna:

Moderna is a leading mRNA technology platform company that is reimagining how medicines are created and delivered. We are committed to giving our people a platform to change medicine and an opportunity to change the world. Our company is built on a culture of belonging, inclusion, and diversity, and we are proud to be recognized as a Science Magazine Top Biopharma Employer and a Fast Company Best Workplace for Innovators.

We offer a comprehensive and innovative suite of benefits, including highly competitive medical, dental, and vision coverage options, flexible spending accounts, lifestyle spending accounts, family care benefits, and more. We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.



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