Associate Director, CMC Regulatory Affairs, International

Overview

In this role you will lead international CMC regulatory activities to support global product development. You’ll manage agency communications, ensure quality CMC sections, and influence submissions across multiple programs. You will work with cross-functional teams to implement strategies, assess regulatory risks, and facilitate health authority interactions. This is a fast-paced, impact-driven position at Moderna, contributing to transformative medicines. You’ll join a mission-driven company with a strong emphasis on collaboration and excellence.

Pay / Benefits

• best-in-class healthcare
• family building benefits
• well-being resources (fitness, mindfulness, mental health support)
• generous paid time off (vacation, holidays, sabbatical, volunteer days, global recharge days)
• savings and investments
• location-specific perks

Responsibilities

• Develop and implement international CMC regulatory strategies for submissions (IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance on regulatory CMC aspects of product development projects
• Review documents for submission readiness and ensure alignment with health authority guidelines
• Lead Regulatory CMC discussions and interactions with health authorities to advance submissions
• Develop regulatory processes and procedures supporting CMC components of 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 and advise on applicability to internal programs
• Oversee multiple programs across therapies (vaccines, oncology, rare diseases)

Key requirements

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
• 10+ years in the pharmaceutical/biotech industry with manufacturing and/or analytical focus
• 8+ years 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
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication

• strategic thinking
• ability to manage multiple projects
• strong written and verbal communication
• CMC regulatory strategy and submissions
• IND/CTA/BLA/MAA knowledge
• CTD format and content

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