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.

We are excited to announce a newly created position within our UK/Ireland Regulatory Team for an Associate Director of Regulatory Affairs, based in our London office. This role offers the unique opportunity to engage in pioneering work that revolutionizes medicine through our groundbreaking mRNA technology, bringing transformative medicines to patients in a timely manner. You will play a key role in managing multiple projects in a fast-paced, results-oriented environment, navigating the complexities of gaining market approval for messenger RNA therapeutics in the UK and Ireland.

Here’s What You’ll Do:

Your key responsibilities will be:

• Working closely with the commercial and Regulatory Organisation to manage multiple regulatory submissions simultaneously.

• Directly contributing to the Regulatory strategy for the UK and Ireland.

• Collaborating with Global Regulatory Science and cross-functional project teams on regulatory strategy development from clinical development to post-market activities.

• Coordinating regulatory submissions, including Scientific Advice, MAAs, Variations, CTAs, and Advertising/Pre-vetting.

• Serving as the point of contact for regulatory agencies related to assigned projects or programs.

Your responsibilities will also include:

• Developing and implementing clinical and pre-clinical regulatory strategies for all development stages.

• Maintaining UK and Irish Product package labelling.

• Leveraging your experience to lead cross-functional team discussions and manage regulatory agency negotiations.

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

• Remove viscosity: Your ability to encourage collective action and streamline processes will be crucial in navigating the regulatory landscape efficiently.

• Prioritize the platform: A focus on leveraging our mRNA platform's potential to drive project success and impact patients' lives directly aligns with our core mission.

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

• A BSc in life science or relevant scientific field (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences).

• A graduate degree and/or post-graduate qualification in a relevant discipline preferred.

• 6-8+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Biologics-focused Regulatory CMC.

• Experience in biologics, vaccines, Rare or Autoimmune Diseases is strongly preferred.

• Strong knowledge of managing regulatory agency negotiations, experience leading and organising Scientific Advice Meetings with MHRA, and current and relevant knowledge of UK/MHRA Medicines Regulations (especially variations).

• Strong ability to lead cross-functional team discussions, and UK-Product launch experience is desirable.

• Good influencing, negotiation, and relationship management skills, and ability to thrive at a high level in a fast paced, dynamic environment.

• Strong written and oral communication skills.

• Experience with developing and implementing gap analysis and effective competitive regulatory strategies that align to clinical considerations and commercial objectives.

• Demonstrate strong organizational skills, including the ability to prioritize workload and to work on multiple complex projects simultaneously.

• Advanced problem-solving ability and a drive to generate compliant regulatory solutions prior to elevation of topics to manager.

• Managing and oversight of MAA submissions to MHRA, extensive knowledge of preparation of major regulatory submissions and supportive amendments, including strong experience with CTD format and eCTD submission builds, including preparation of Module 1 documents.

• Experience in interpretation of regulations, guidelines, and policy statements.

• Demonstrate a proven ability to work both independently and within project teams, committees, etc. to achieve group goals.

• Use of the VEEVA platform for the authoring and approval of documentation would be an advantage.

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 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.

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 leavesandaccommodations@modernatx.com.

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