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 dynamic and forward-thinking Director, Regional Regulatory Strategist to lead the regulatory strategy and execution for interactions with the European Medicines Agency (EMA) for assigned programs. As an individual contributor based in London, you will also collaborate with Country Regulatory Leads across EU and international markets to develop localized regulatory strategies and support global submissions.

This is an exciting opportunity for a regulatory professional eager to shape the future of mRNA medicines. The ideal candidate will bring a creative and agile mindset, anticipating challenges inherent in the evolving regulatory landscape for a novel modality like mRNA. Your strategic leadership will ensure robust regulatory planning and engagement, from early-stage filings through lifecycle management, including accelerated pathways and pediatric development strategies.

Here's What You’ll Do:

Your key responsibilities will be:

• Serving as the EMA primary contact point for your assigned program(s), leading regulatory engagement strategy across all interactions.

• Driving the development and execution of EU regulatory strategy in alignment with Global Regulatory Teams and Country Regulatory Leads.

• Managing content and format for EMA-related regulatory submissions such as meeting requests, briefing documents, orphan drug applications, pediatric plans, MAA, expedited pathways, DSURs, and more.

• Identifying regulatory risks and mitigation strategies in support of timely approvals and successful lifecycle management of Moderna’s programs.

• Contributing regulatory expertise to regional and global planning discussions, ensuring integration of EMA requirements into global development plans.

• Ensuring strong collaboration and knowledge exchange with international teams to support regulatory filings and queries across other global markets.

Your responsibilities will also include:

• Supporting Country Regulatory Leads in the EU and international markets by advising on local regulatory strategy, dossier content, and regulatory authority interactions.

• Coordinating end-to-end regulatory submission activities related to assigned program(s) to ensure timely and high-quality deliverables.

• Preparing and delivering impactful communications and presentations to internal stakeholders and health authorities as needed.

• Providing expert input into key cross-functional initiatives, such as CTA content design and submission planning.

• Staying informed about evolving EMA regulations, guidance documents, and policy trends impacting mRNA technologies, and proactively adjusting strategy as needed.

• Helping shape Moderna’s internal regulatory processes for new modalities, driving continuous innovation and regulatory excellence.

The key Moderna Mindsets you’ll need to succeed in the role:

• We question convention because proven models don’t always fuel the future. This role is designed for someone ready to challenge the traditional regulatory playbook and help define the path forward for mRNA medicines in the EU regulatory environment.

• We digitize everywhere possible using the power of code to maximize our impact on patients. Your work will intersect with digitally enabled platforms and innovative submission strategies. You’ll have opportunities to engage with teams pioneering the use of Generative AI tools to drive regulatory insights and submission planning.

Here’s What You’ll Bring to the Table:

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

• 10+ years of experience in the pharmaceutical industry. 7+ years of experience in Regulatory strategy

• Strong knowledge of current EU and International regulations from preclinical stage to post-approval

• 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 within project teams, committees, etc. to achieve business goals and objectives in a fast-paced environment

• Ability to effectively collaborate effectively in a dynamic, cross-functional, matrixed environment to drive meeting each program’s critical regulatory milestones

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

• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.   Fluency in English is required.  The knowledge of other European languages is a plus.

• 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.  That’s why our global benefits and well-being resources are designed to support you—at 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
• Savings and investments
• 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.