Director, Regulatory Affairs Strategy

Location: Greater London

*
* 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 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’ll 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.
** Here’s

What You’ll 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 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…