Director, Global Regulatory Science CMC, Respiratory Products

The Role:

The Director, Global Regulatory Science CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a product’s lifecycle.   The Director will manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The Director will be expected to provide guidance to the product teams supporting products in their portfolio.  In addition, the individual will be responsible for preparation, review, and approval of CMC and Quality related Health Authority 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.  Effective communication skills will be critical to overall success.  The individual will also be expected to mentor and develop their direct reports.    The Director, Global Regulatory Science CMC can be based either at the Norwood, MA or Basel, Switzerland site.

Here’s What You’ll Do:

• Develop/implement effective CMC regulatory strategies for 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

• Develop 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

• Perform assessment of manufacturing change controls

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

• Lead oversight of multiple programs in Respiratory franchise

Here's What You'll Need:

• Bachelor’s degree in a scientific/engineering discipline

• 12+ years of experience in the pharmaceutical/biotech industry

•  8 + years of experience in Regulatory CMC

• Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions

• Strong 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

• Prior management experience required

• Excellent interpersonal skills for internal and external negotiation and influence

• Exceptional written and oral communication skills

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

• Bachelor’s degree with 15 years of experience in the pharmaceutical/biotech industry

• MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, 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

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 a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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