Director, Global Regulatory CMC - Rare Diseases

The Role:

The Director, Global Regulatory-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 may 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, including but not limited to Rare Diseases.  In addition, the individual will be responsible for preparation, review, and approval 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.  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-CMC will be based at the Norwood or Cambridge, MA sites.

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

• 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

• Potentially has oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

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

Minimum Qualifications

• Bachelor’s degree in a scientific/engineering discipline

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

• Minimum of 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

• This role is expected to be in office 70% of the time with flexibility to work from home up to 30%.

Preferred Qualifications

• MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable

• 15+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

• 8+ years of experience in Biologics focused Regulatory CMC

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+ commun