Director, Regulatory Affairs Strategy, UK in London

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you will 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.

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 Moderna's 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. You will 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.

Here’s What You’ll Do:

• 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 Moderna’s 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 affiliate’s 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 you’ll need to succeed in the role:

• “We behave like owners. The solutions we’re building go beyond any job description.” In this sole-contributor role, your ability to take full ownership of the UK/Ireland regulatory agenda—across strategy, execution, compliance and innovation—will 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, you’ll have the chance to influence and integrate digital solutions that streamline regulatory submissions and elevate operational efficiency.

Here’s What You’ll 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/Oncology 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 Moderna’s 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. That’s why our global benefits and well-being resources are designed to support you—at 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.
• Savings and investments 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.