Associate Director, Cmc Regulatory Science - Uk

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 London, a global hub for scientific research and innovation. Our London office focuses on commercial operations, ensuring the delivery of our revolutionary products to the UK market. We're seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.

In this pivotal role, you will be responsible for defining and driving the CMC regulatory strategy for both UK-based and global projects, focusing on compliance and the successful submission of regulatory dossiers for our mRNA products. As a key strategic leader, you will provide expert regulatory guidance to cross-functional teams and play a critical role in establishing CMC compliance frameworks that support the development, approval, and commercialization of transformative medicines.

You will be the primary interface with regulatory bodies, including the MHRA, ensuring that our regulatory strategies are aligned with both clinical and commercial goals. Your influence will extend across departments, as you lead cross-functional collaborations that ensure the successful delivery of regulatory submissions while proactively navigating regulatory complexities.

This role is based in our London office (Victoria) and will require regular travel to our new, state-of-the-art manufacturing facility in Harwell, Oxfordshire.

Here's What You'll Do:
Your key responsibilities will be:
Develop and lead comprehensive CMC regulatory strategies for submissions in the UK and internationally, ensuring alignment with product development and commercialization efforts.

Provide strategic oversight for the preparation and management of CMC and Quality-related regulatory submissions, ensuring compliance with global standards.

Lead cross-functional teams, including Manufacturing, Quality, and Process Development, ensuring cohesive regulatory processes and timely responses to regulatory inquiries.

Directly engage with regulatory agencies, including MHRA, to facilitate efficient reviews and approvals of submissions.

Champion the development of scalable regulatory submission processes, enhancing operational efficiency within the team.

Your responsibilities will also include:
Proactively managing regulatory risks and developing mitigation strategies in response to evolving global requirements.

Leading complex decision-making processes related to CMC regulatory matters.

Mentoring and providing leadership to junior regulatory professionals, fostering a culture of continuous learning and innovation.

The key Moderna Mindsets you'll need to succeed in the role:
Act with urgency:The rapidly evolving mRNA landscape requires fast-paced regulatory responses to ensure timely submissions and approvals.

Prioritize the platform:Focus on the holistic impact of regulatory decisions on Moderna's mRNA platform, ensuring long-term sustainability beyond individual products.

What You'll Bring to the Table:

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 focused Regulatory CMC

Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions,

Knowledge of current CMC regulations outside of the US, as well, is preferred,

Knowledge of and broad experience with regulatory procedures and legislation 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

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
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, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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 peopleare 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.

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 modernatx.com/careers 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 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. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at ****** .
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