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Senior Director, CMC Regulatory Affairs, Oncology
About the position
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its presence in Marlborough, Massachusetts, home to one of our key technical development and manufacturing centers. Here, we're pushing the boundaries of mRNA science by anchoring critical operations that support the global development and supply of our transformative therapies. Marlborough offers a unique environment that blends hands-on innovation with large-scale impact. Join our team in Marlborough and play a pivotal role in shaping the next chapter of Moderna’s mRNA platform. You will lead Moderna’s Regulatory CMC strategy for its oncology portfolio, managing a team of experts and steering regulatory submissions through all development stages. This position is a hybrid of strategic vision, operational precision, and team mentorship—positioned to drive regulatory excellence in support of Moderna’s mission to transform patients’ lives through mRNA technology. You will serve as a senior voice in cross-functional governance structures, own regulatory interactions with global authorities, and ensure streamlined execution of complex deliverables across manufacturing, quality, and development. Your leadership will directly impact how quickly and safely Moderna brings its oncology therapies to market. This role offers the opportunity to engage closely with digital and AI tools that are shaping the next generation of regulatory science and operational excellence.
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.
Requirements
- MS/PhD degree in a scientific/engineering discipline preferred
- 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
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
