Senior Manager, Global Regulatory Science CMC - Oncology

The Role:

The Sr. Manager, Global Regulatory CMC will be responsible for supporting regulatory CMC activities for one or more programs in their portfolio, including but not limited to Oncology and Rare Diseases.  The Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy. Effective communication skills will be critical to overall success. The Sr. Manager 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 and will be based at the Norwood, MA site.

Here’s What You’ll Do:

• Support development of 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

• Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions

• Support development of regulatory processes and procedures to facilitate 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

• Support multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

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

Minimum Qualifications

• BA/BS degree in a scientific/engineering discipline

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

• 2.5 to 3 years of experience in Regulatory CMC

• Knowledge of current US and EU regulations and cGMP

• Experience with CTD format and content regulatory filings

• Exceptional written and oral communication

Preferred Qualifications

• BS or MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is desirable

• 8+ years of experience in regulatory in the pharmaceutical/biotech industry

• 4+ years of experience in Regulatory CMC is desirable

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 opportu