Senior Director, CMC Regulatory Affairs, Oncology

The Role:

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.

Here's What You’ll Do:

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.

The key Moderna Mindsets you’ll need to succeed in the role:

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

• We digitize everywhere possible using the power of code to maximize our impact on patients. You will work in an environment that embraces data-driven automation and generative AI, applying digital solutions wherever feasible to streamline regulatory operations and submissions.

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

• Education: MS/PhD degree in a scientific/engineering discipline preferred

• Experience: 10+ years of experience in the pharmaceutical/biotech industry. 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions

• Specific Certifications or Training: 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

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• 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

The salary range for this role is $196,700.00 - $353,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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 opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Our Working Model 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.  Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [email protected]. 

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-KF1

-