Associate Director, Global Regulatory Science CMC, Therapeutics Programs

The Role:
The Associate Director, Global Regulatory Science CMC – Therapeutics Programs, will be responsible for leading regulatory CMC strategy and support for products in clinical development (IND, CTA) and commercial product registrations (BLA, MAA), including, post-approval variations.  The Associate Director will be responsible for developing regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with regulatory requirements and business priorities. The individual will be expected to provide guidance to CMC teams and collaborate within the Global Regulatory CMC team. The Associate Director will be responsible for preparation of CMC and Quality related agency correspondence and regulatory submissions.  The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on maintaining a new, transformative medicine for patients.  The Associate Director will be based at the Norwood, MA site.

Here’s What You’ll Do:

• Develop/implement effective regulatory CMC strategies for clinical trial applications (IND, CTA) and commercial registrations (BLA, MAA), and identify regulatory risks.

• Provide regulatory CMC advice to manufacturing and quality teams.

• Review documents for submission-readiness, to ensure that all submissions conform to regulatory requirements.

• Lead regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions.

• Assess change controls.

• Support development of regulatory processes and procedures.

• Support the creation and maintenance of CMC submission tools and templates.

• 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 US CMC regulations, including CTD format and content of CMC regulatory submissions,

• Knowledge of current CMC regulations outside of the US, as well, is preferred,

• Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM),

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet 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 th