Director, Regulatory Affairs Strategy, UK

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.

We are seeking a proactive agile and highly experienced Director to join our UK/Ireland Regulatory Team in London. This newly created individual contributor role offers the opportunity to shape and drive the local regulatory strategy for Modernas pioneering mRNA portfolio. You will lead the charge on national regulatory execution directly engaging with the MHRA and HPRA and enabling rapid access to transformative therapies. Youll play a central role in both the clinical and commercial trajectory of our programs ensuring regulatory excellence through all phases of development and post-approval. This is an exciting hands-on opportunity for someone who thrives in a high-paced environment and is passionate about bringing disruptive innovation to the healthcare landscape in the UK and Ireland.

Heres What Youll Do:

Your key responsibilities will be:

• Develop and execute a long-term regulatory strategy tailored to the UK and Irish markets ensuring alignment with global regulatory objectives.

• Serve as the primary regulatory contact for MHRA and HPRA across assigned projects and programs.

• Manage and deliver multiple complex regulatory submissions including MAAs variations CTAs and Scientific Advice packages.

• Drive end-to-end lifecycle activities including labelling PIP processes advertising and pre-vetting and strategic filings for new indications.

• Provide strategic regulatory input across clinical pre-clinical and commercial programs through all development stages.

• Collaborate closely with the Global Regulatory Science (GRS) function and local affiliate stakeholders to align on business-critical deliverables.

• Monitor and interpret evolving UK and Irish regulatory frameworks assessing impact on Modernas pipeline and product portfolio.

Your responsibilities will also include:

• Create and maintain regulatory SOPs and working procedures tailored to the UK/Ireland affiliate.

• Participate in health authority inspections and oversee CAPAs deviations and follow-up action plans.

• Support clinical trial strategies and submissions within the UK/Ireland ensuring compliance and optimal timelines.

• Engage in industry consultations and pipeline meetings contributing to policy shaping through commentary on draft legislation.

• Actively support the execution of the affiliates commercial strategy by aligning regulatory efforts with market goals.

• Partner cross-functionally with Quality PV Market Access Supply Chain Government Affairs Medical Affairs and the UK General Manager to drive integrated affiliate success.

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

• We behave like owners. The solutions were building go beyond any job description.
  In this sole-contributor role your ability to take full ownership of the UK/Ireland regulatory agendaacross strategy execution compliance and innovationwill be essential to delivering impact without boundaries.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  With increasing opportunity to engage with regulatory tech innovation and Generative AI youll have the chance to influence and integrate digital solutions that streamline regulatory submissions and elevate operational efficiency.

Heres What Youll Bring to the Table:

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

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

• 10 years of experience in the pharmaceutical/biotech industry with substantial experience in Biologics-focused Regulatory Affairs.

• Experience in biologics/vaccines/Infectious Diseases/Oncoloy and Rare Diseases is strongly preferred.

• Leadership in managing regulatory agency negotiations experience leading and organising Scientific Advice Meetings (SAM) with MHRA new MAAs and strong current knowledge of UK/MHRA Medicines Regulations.

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

• Strong 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.

• Track record of developing and implementing gap analysis and effective competitive regulatory strategies that align to clinical considerations and commercial objectives.

• Excellent 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.

• Guiding overseeing and managing MAA submissions to MHRA guiding and participating in content development for major regulatory submissions such as new indications line extensions strategic label updates including strong experience with CTD format and eCTD submission builds including preparation of Modules 1-5 documents.

• Advanced 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.

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

• As part of Modernas commitment to workplace safety this role may require an enhanced pre-employment check.

Pay & Benefits

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.

• Best-in-class healthcare plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness mindfulness and mental health support

• Family building benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savingsandinvestments to help you plan for the future

• 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 .

-