Associate Director, CMC Regulatory Affairs, International

Job title: Associate Director, CMC Regulatory Affairs, International

About the Role Join Moderna to advance mRNA science and transform medicine. This role serves as a pivotal CMC Regulatory Affairs leadership position responsible for preparing and overseeing CMC and Quality-related agency communications and regulatory submissions for global product development. You will lead regulatory activities to deliver high-quality CMC documentation and ensure compliance across international submissions.

What You'll Do

• Develop and implement effective global CMC regulatory strategies for international submissions, including INDs, CTAs, BLAs, MAAs, and other regional regulatory applications.
• Lead the preparation, review, and oversight of CMC and Quality-related agency correspondence and regulatory submissions.
• Govern and coordinate CMC submission activities to ensure alignment with global regulatory requirements and business objectives.
• Identify, assess, and proactively mitigate regulatory risks impacting product development, lifecycle management, and market access activities.
• Provide strategic CMC regulatory guidance to cross-functional product development teams throughout the product lifecycle.
• Review regulatory documentation for submission readiness, ensuring compliance with applicable health authority requirements, regulations, and guidance.
• Lead CMC regulatory discussions, negotiations, and interactions with international health authorities to facilitate efficient review and approval of submissions.
• Develop, implement, and continuously improve regulatory processes and procedures supporting CMC components of global regulatory filings.
• Support the creation, maintenance, and optimization of CMC submission templates and associated regulatory documentation standards.
• Partner closely with Manufacturing, Technical Operations, Quality, and Development teams to provide regulatory guidance on CMC-related matters.
• Evaluate CMC change controls and provide regulatory assessments to support implementation strategies and compliance requirements.