Associate Director, Global Regulatory Science, CMC

The Role Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing CMC and Quality related agency correspondence and regulatory applications, governing CMC submissions, and providing regulatory compliance support for the development of global products, with focus on Latin America (LATAM). The successful candidate will lead and support all regulatory activities, ensuring the delivery of high-quality CMC sections of regulatory documentation. This role demands a dynamic individual capable of managing multiple projects in a fast and results-oriented environment, dedicated to bringing a new generation of transformative medicines to patients.

Here’s What You’ll Do

• Develop and implement effective CMC regulatory strategies for post-approval submissions in LATAM 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 the review and approval of submissions. • Develop regulatory processes and procedures to support the 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. • Offer interpretations of regulatory guidance documents, regulations, and directives, advising on their applicability and impact on internal programs. • Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology, and/or rare diseases).

The key Moderna Mindsets you’ll need to succeed in the role

• Pursue options in parallel: This role requires a strategic thinker who can explore multiple avenues simultaneously to ensure the most efficient and effective regulatory strategies. • Act with urgency: Given the fast-paced and result-oriented environment, acting swiftly and decisively is crucial to meet deadlines and deliver transformative medicines to patients.

Here’s What You’ll Need (Basic Qualifications)

• BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required. • 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 certain therapeutic areas (vaccines, oncology and/or rare diseases) • Strong knowledge of current LATAM regulations • Strong knowledge of cGMP • Strong experience with CTD format and CMC content of regulatory filings • Exceptional written and oral communication