Senior Director, CMC Regulatory Affairs, Oncology

Overview

The Role:

Joining Moderna offers the opportunity to be part of a pioneering team 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 provides a challenging and rewarding career with the potential to impact patients' lives worldwide.

Moderna is expanding its presence in Marlborough, Massachusetts, home to a key technical development and manufacturing center. This location anchors critical operations that support the global development and supply of our therapies. Marlborough offers an environment that blends hands-on innovation with large-scale impact. Join our team in Marlborough and contribute to Moderna’s mRNA platform development.

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 combines strategic vision, operational precision, and team mentorship to drive regulatory excellence in support of Moderna’s mission. You will serve as a senior voice in cross-functional governance, own regulatory interactions with global authorities, and ensure streamlined execution of complex deliverables across manufacturing, quality, and development.

Your leadership will impact how quickly and safely Moderna brings oncology therapies to market. This role offers the opportunity to engage with digital and AI tools shaping the next generation of regulatory science and operational excellence.

Your key responsibilities will be:

• 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.

• Your responsibilities will also include:

• 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.

• We behave like owners. In this strategic leadership role, you will take full ownership of regulatory direction and delivery—ensuring sustainable, scalable, and impactful solutions beyond the role’s formal boundaries.

• We digitize everywhere possible using data-driven automation and generative AI to streamline regulatory operations and submissions.

• Education: MS/PhD in a scientific/engineering…