Senior Director, CMC Regulatory Affairs, Oncology

September 29, 2026

Other Jobs To Apply

No other job posts for this day.

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

Back to blog

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...