Manager, Regional Regulatory Strategist

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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. Were seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.

As a Manager Regional Regulatory Strategist you will play a critical role in advancing the global regulatory path for Modernas mRNA programs in the European Union and international markets. This role is designed for a forward-thinking and agile regulatory professional who thrives in a fast-paced innovation-driven environment. You will support the development and execution of regulatory strategy with the EMA and other international health authorities ensuring scientific strategic and operational excellence throughout the product lifecycle. Your work will contribute directly to enabling cutting-edge mRNA medicines to reach patients worldwide by facilitating health authority interactions managing submission timelines and mitigating regulatory risk. This is a pivotal position for someone looking to be at the frontier of regulatory science while gaining exposure to evolving global frameworks complex filings and international regulatory pathways. This individual contributor role based in our London office places you at the intersection of regulatory leadership and scientific advancement.

Heres What Youll Do:

Your key responsibilities will be:

• Supporting the development and execution of regulatory strategy for assigned programs in the EU and international markets in collaboration with Global Regulatory Leads Regional Regulatory Strategists and Country Regulatory Leads

• Preparing and contributing to regulatory submissions including Scientific Advice meeting requests briefing documents clinical trial applications orphan drug designations pediatric plans expedited pathway applications DSURs and marketing authorization applications (MAA)

• Coordinating aspects of regulatory submissions relevant to the assigned program(s) ensuring alignment with global strategy and timelines

• Supporting regulatory interactions with the EMA and other international health authorities

• Engaging with cross-functional regulatory teams to ensure consistency compliance and strategy execution

Your responsibilities will also include:

• Identifying assessing and managing regulatory risks associated with assigned program(s)

• Tracking following up and archiving correspondence regulatory commitments and queries from EMA and international agencies

• Working independently and collaboratively in matrixed project teams to achieve program goals

• Applying critical thinking to anticipate potential regulatory hurdles and proactively address challenges specific to mRNA as a novel modality

• Contributing to continuous improvement and innovation within regulatory processes

The key Moderna Mindsets youll need to succeed in the role:

• We question convention because proven models dont always fuel the future.
  In this role you will be navigating the complexities of novel mRNA modalities which require a departure from traditional regulatory paradigms. Embracing unconventional thinking will empower you to shape and influence emerging regulatory strategies and accelerate development.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  You will be expected to engage with digital tools and platforms to manage global submissions and regulatory workflows ensuring efficiency traceability and responsiveness in a dynamic regulatory environment.

Heres What Youll Bring to the Table:

• Degree in Life Science or related discipline advanced degree preferred (PharmD MSc PhD)

• 5 years of experience in the pharmaceutical industry. 3 years of experience in Regulatory strategy

• Strong experience with CTD format and content of regulatory filings

• Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration line extension and license maintenance in the EU and/or relevant International markets

• Ability to work independently to manage multiple projects in a fast-paced environment

• Ability to effectively collaborate effectively in a dynamic cross-functional matrix environment to drive meeting each programs critical regulatory milestones

• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned

• A desire to be part of a high-growth transformational company that is Bold Relentless Curious and Collaborative

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

• 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
• Savingsandinvestments
• 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 theinfrastructure 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 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 persons 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 consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were 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 accommodation 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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