Associate Director, Global Regulatory CMC

The Role

The Associate Director, Global Regulatory CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a product's lifecycle. The Associate Director will develop global regulatory CMC strategies and collaborate with key stakeholders to execute these strategies in alignment with business priorities. The individual will provide guidance to product teams and prepare CMC and Quality related agency correspondence and regulatory applications. The candidate will manage multiple projects in a fast-paced environment to deliver on bringing transformative medicines for patients. Developing regulatory strategies for the products in the portfolio will be a key success component.

Here’s What You’ll Do

• Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks
• Provide guidance for regulatory CMC aspects of product development projects
• Review documents for submission-readiness, ensuring they conform to health authority guidelines
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
• Perform assessment of manufacturing change controls
• Support development of 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
• Provide interpretation of regulatory guidance documents, advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

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

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required
• 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
• 5+ years of experience in Biologics focused Regulatory CMC
• Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
• 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
• Ability to work independently
• Exceptional written and oral communication skills

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

Our Working Model

We are focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Equal Opportunities

We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.