Associate Director, International Regulatory Strategy

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.

This individual contributor role is central to Modernas international regulatory strategy focusing on mRNA programs across EU and ex-US markets. The Associate Director International Regulatory Strategy will shape and execute regulatory approaches working closely with country RA leads Regional Regulatory Strategists and Global Regulatory Leads. You will be instrumental in bridging global and local regulatory objectives helping to drive submissions manage agency interactions and mitigate risks. This role requires both strategic vision and operational execution suited for someone who thrives in dynamic cross-cultural fast-paced environments. With close alignment to EMA and other international health authorities youll ensure that our regulatory pathways are optimized for impact and innovation. The position is based in London and represents a high-visibility opportunity to support Modernas global mRNA mission.

Heres What Youll Do:

Your key responsibilities will be:

• Act as a strategic liaison between Global and Regional Regulatory Strategists and Country RA leads to drive cohesive international regulatory strategies across assigned mRNA programs.

• Develop and maintain alignment with global regulatory strategy Global Regulatory Sub-Teams and cross-functional project teams.

• Support Country RA Leads in compiling and submitting MAAs variations and renewals for international markets.

• Identify and mitigate regulatory risks in coordination with regional and global stakeholders for assigned program(s).

Your responsibilities will also include:

• Support EMA interactions including coordination of briefing documents meeting requests and responses to questions for assigned programs.

• Monitor evolving regulatory landscapes in international markets and integrate changes into the global regulatory strategy.

• Collaborate cross-functionally to ensure submission readiness and documentation quality across all relevant jurisdictions.

• Respond to agency information requests and manage regulatory meetings at international levels.

• Contribute to regulatory process optimization and help embed best practices across the Regulatory Strategy group.

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

• We obsess over learning. We dont have to be the smartest we have to learn the fastest.
  This role demands staying abreast of evolving international regulations and being responsive to rapid changes across health authority expectations requiring an agile learners mindset.

• We behave like owners. The solutions were building go beyond any job description.
  As a cross-functional regulatory strategist interfacing globally you will take full ownership of strategy execution and health authority engagement contributing well beyond the narrow confines of the role.

Heres What Youll Bring to the Table:

• BA/BS degree in a scientific/engineering/healthcare discipline required Masters PharmD or PhD preferred.

• 7 years of experience in the Pharmaceutical industry preferred.

• 5 years of experience in Regulatory strategy or relevant training/experience preferred.

• Knowledge of and broad experience with regulatory procedures and legislation for drug development product registration line extension and license maintenance in the EU and International countries.

• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements (i.e. CTD content and format).

• Ability to work both independently and collaboratively across geographies within global regulatory and project teams to achieve business goals and objectives in a fast-paced environment.

• Effectively communicate the regulatory strategy risks mitigations and overall plans to Project Teams and senior management as relevant.

• Demonstrated strategic thinking problem-solving and prioritization skills in a fast-paced environment.

• 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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