Global CMC Regulatory Leader — Associate Director

Regulatory Jobs; Norwood (MA); Hybrid; USD 143,000 - 257,000; Full time

Job summary

Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications.

The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory knowledge, CTD experience, and the ability to manage multiple programs across vaccines, oncology, and rare diseases within a 70/30 in-office model.

Qualifications

• Bachelor’s degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field.
• 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 on vaccines, oncology and/or rare diseases.
• Strong knowledge of current EU and ROW regulations.
• Strong knowledge of CGMP and CTD format and content regulatory filings.
• Exceptional written and oral communication.

Responsibilities

• Develop CMC regulatory strategies for international submissions (IND/CTA/BLA/MAA) and identify regulatory risks.
• Provide guidance on regulatory CMC aspects of product development projects.
• Review documents for submission readiness, ensuring conformity to health authority guidelines.
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approvals.
• Develop regulatory processes and procedures to support CMC components of regulatory submissions.
• Support creation and maintenance of CMC submission templates.
• Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls.
• Interpret regulatory guidance documents and advise on applicability to internal programs.
• Oversee multiple programs in vaccines, oncology, and/or rare diseases.

Education

B.S. in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

M.S. in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

Job description

Moderna is seeking an Associate Director, Global Regulatory Affairs, CMC, to lead and oversee regulatory activities for CMC and Quality, coordinating worldwide submissions and agency communications.

The role requires 10+ years in pharma/biotech with strong EU/ROW regulatory knowledge, CTD experience, and the ability to manage multiple programs across vaccines, oncology, and rare diseases within a 70/30 in-office model.