Moderna · 12 hours ago
Senior Director, CMC Regulatory Affairs, Oncology
Marlborough, MA
Full-time
Hybrid
Director/Executive
$197K/yr - $353K/yr
10+ years expModerna is a pioneering company revolutionizing medicine through mRNA technology, and they are seeking a Senior Director for CMC Regulatory Affairs in Oncology. The role involves leading regulatory strategies and managing a team to ensure successful submissions and compliance in the oncology portfolio.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
Responsibilities
Lead development and execution of regulatory CMC strategies for oncology submissions including IND, CTA, BLA, and MAA filings
Oversee a team of regulatory professionals via direct and matrix management structures
Serve as the key CMC regulatory contact in cross-functional governance forums for oncology programs
Provide strategic guidance to manufacturing and quality teams on complex regulatory and technical issues
Lead preparation and review of agency correspondence to ensure submission-readiness and adherence to global regulatory expectations
Champion cross-functional initiatives that simplify and enhance business processes across Regulatory, Technical Development, and Quality
Mentor, develop, and inspire regulatory professionals, ensuring high team engagement and technical growth
Act as primary liaison for Regulatory CMC interactions with health authorities
Support creation and refinement of global CMC templates and knowledge assets
Represent Moderna’s oncology programs with rigor, urgency, and precision, helping to accelerate delivery of transformative therapies to patients
Delivering robust interpretation of domestic and international regulatory guidance to internal teams
Driving alignment within the broader regulatory affairs function on shared priorities and global strategies
Ensuring internal compliance with GxP regulations, SOPs, data integrity standards, and documentation expectations
Executing activities in accordance with assigned training and requalification plans
Leading or contributing to initiatives that explore the use of Generative AI and digital tools to enhance regulatory science and operational efficiency
Applying good documentation practices to ensure readiness for audits and inspections
Contributing to a culture of learning and adaptability, aligned with Moderna’s high-speed innovation environment
Qualification
Required
10+ years of experience in the pharmaceutical/biotech industry
8+ years of experience in Regulatory CMC, including DMF/ASMF submissions
Strong knowledge of current US, EU and ROW regulations
Strong experience with CTD format and content for regulatory filings
Demonstrated ability to learn in order to gain a strong understanding of FDA, EMA and ICH guidelines
Preferred
MS/PhD degree in a scientific/engineering discipline preferred
Benefits
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-24
legacy.thefly.com
2026-01-23
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