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 products lifecycle. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The individual will be expected to provide guidance to the product teams and will be responsible for preparation of CMC and Quality related agency correspondence and regulatory applications.  The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients.  Development of regulatory strategy for the products in our 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, to ensure that all submissions 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

• Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls

• Provides interpretation of regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

Here’s What You’ll Bring to the Table:

• 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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• 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. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and