Associate Director, Global Regulatory Science, CMC

ModernaTX; Oxford; On-site; GBP 70,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company in Oxford is seeking a dedicated Associate Director for Global Regulatory Science. This role involves leading regulatory strategies for mRNA programs and ensuring compliance through the entire product lifecycle. The ideal candidate has a PhD in a related field and extensive experience in the pharmaceutical industry. Join a pioneering team focused on innovative patient care.

Benefits

Quality healthcare and insurance benefits

Lifestyle Spending Accounts

Free access to fitness, nutrition and mindfulness classes

Generous paid time off, including vacation and sabbatical

Qualifications

• 8 years of experience in the pharmaceutical / biotech industry.
• 5 years of experience in biologics- and/or vaccines-focused Regulatory CMC.
• Direct experience with current global CMC regulations.

Responsibilities

• Develop and implement regulatory CMC strategies for global submissions.
• Lead regulatory CMC input for quality and manufacturing activities.
• Prepare and oversee submission of CMC documents to Health Authorities.

Skills

Program assessment

FDA Regulations

Manufacturing & Controls

Leadership Experience

Negotiation

Education

BS / MS / PhD in Molecular Biology, Pharmaceutics, Chemistry, or Chemical Engineering

Job description

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 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 Harwell, a global hub for scientific advancement in the UK. Our Harwell office will be home to roles critical to our mission of delivering mRNA medicines to patients worldwide. Join us at this exciting location where you’ll help shape the future of healthcare innovation in one of the UK’s most dynamic science and technology campuses.

This role is central to Moderna’s global regulatory success. As Associate Director Global Regulatory Science CMC you will lead regulatory CMC strategy and execution for one or more mRNA programs. You will be instrumental in developing global strategies and ensuring that regulatory submissions are flawlessly executed across the product lifecycle including pre‑ and post‑approval phases. You’ll collaborate closely with Manufacturing, Quality, and Analytical Development groups to guide regulatory compliance and shape submissions that meet both scientific rigor and business needs. You’ll also be responsible for preparing key regulatory documents and leading Health Authority interactions. This role requires a technically strong action‑oriented leader who thrives in fast‑paced environments and is eager to contribute to Moderna’s transformative impact on patient care through mRNA technology.

Key Responsibilities

• Developing and implementing regulatory CMC strategies for global IND / / BLA / MAA submissions covering both new applications and post‑approval filings.
• Leading regulatory CMC input for quality and manufacturing activities with a focus on risk identification and mitigation.
• Preparing and overseeing the submission of CMC and Quality‑related documents to global Health Authorities.
• Driving Health Authority interactions and ensuring alignment between internal teams and external expectations.
• Guiding stakeholders on regulatory implications of changes to process manufacturing or analytical controls.
• Reviewing submission documents for readiness ensuring compliance with global regulatory standards.
• Advising Quality, Manufacturing and Development teams on regulatory directives guidance and emerging changes.
• Participating in the design and upkeep of regulatory tools, processes and CMC submission templates.
• Assessing and interpreting change controls for regulatory impact.
• Supporting cross‑functional collaboration and embedding a global regulatory mindset into CMC initiatives.

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

We obsess over learning. We don’t have to be the smartest; we have to learn the fastest.

You will operate at the cutting edge of regulatory science navigating global regulatory environments while rapidly absorbing emerging CMC guidance and translating it into actionable strategy.

We digitize everywhere possible using the power of code to maximize our impact on patients.

Your work will be amplified by digital tools and data‑driven systems. Embracing Moderna’s commitment to digital innovation you’ll contribute to modernizing regulatory operations while staying close to breakthroughs in Generative AI.

Qualifications

• BS / MS / PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering or closely related field is required.
• 8 years of experience in the pharmaceutical / biotech industry manufacturing and/or analytical focus.
• 5 years of experience in biologics‑ and/or vaccines‑focused Regulatory CMC.
• Direct experience and strong knowledge of current global CMC regulations including CTD format and content of CMC regulatory submissions.
• Knowledge of and broad experience with regulatory procedures related to CMC aspects of drug development product registration and post‑approval lifecycle management (LCM).
• Ability to effectively collaborate in a dynamic cross‑functional matrix environment to meet critical regulatory milestones.
• Ability to work independently.
• Exceptional written and oral communication.

Benefits

• Quality healthcare and insurance benefits.
• Lifestyle Spending Accounts to create your own pathway to well‑being.
• Free premium access to fitness, nutrition and mindfulness classes.
• Family planning and adoption benefits.
• Generous paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days and a discretionary year‑end shutdown.
• Savings and investments.
• Location‑specific perks and extras!

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 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.

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.

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

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

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 committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, orientation, marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Employment Type

Full‑Time

Key Skills

Program assessment, FDA Regulations, Manufacturing & Controls, Program Evaluation, budget forecast, Research Experience, Operations Management, Research & Development, Strategic Planning, Contract Management, Leadership Experience, negotiation

Director

Years of experience: years

Vacancy: 1