Director, Regional Regulatory Strategist

Moderna; Oxford; On-site; GBP 85,000 - 110,000; Full time

Job summary

A leading biotechnology company in the UK is seeking a Director, Regional Regulatory Strategist to lead regulatory strategy for EU programs. The ideal candidate will have over 10 years in the pharmaceutical sector, focusing on regulatory engagement and compliance. This role involves collaboration with various global teams and requires robust knowledge of EU regulations. The position offers a competitive benefits package and a dynamic work environment focused on innovation.

Benefits

Quality healthcare and insurance benefits

Lifestyle Spending Accounts for well-being

Free premium access to fitness, nutrition, and mindfulness classes

Generous paid time off

Qualifications

• 10+ years of experience in the pharmaceutical industry; 7+ years in Regulatory strategy.
• Strong knowledge of current EU and international regulations from preclinical stage to post-approval.
• Experience with major regulatory submissions and amendments (i.e., CTD content and format).

Responsibilities

• Lead regulatory engagement strategy across all interactions with the EMA.
• Drive development and execution of EU regulatory strategy in alignment with Global Regulatory Teams.
• Identify regulatory risks and mitigation strategies for timely approvals.

Skills

Regulatory strategy

Collaboration skills

Communication skills

Knowledge of EU regulations

Education

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

Job description

Overview

The Role: Joining Moderna offers the opportunity to be part of a pioneering team revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you’ll be part of a growing organization, collaborating with exceptional colleagues and strategic partners worldwide to contribute to global health initiatives. Moderna is expanding its presence in London, focusing on commercial operations to deliver our products to the UK market. We are seeking talents ready to contribute to our mission and transform 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. Based in London, you will 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 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.

Responsibilities

• Serving as the EMA primary contact point for 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.

Qualifications

• Degree in Life Science or related discipline; advanced degree preferred (PharmD, MSc, PhD).
• 10+ years of experience in the pharmaceutical industry; 7+ years in Regulatory strategy.
• Strong knowledge of current EU and international regulations from preclinical stage to post-approval.
• Knowledge of regulatory procedures and legislation for drug development, product registration, line extension, and license maintenance in the EU and international markets.
• Experience with major regulatory submissions and amendments (i.e., CTD content and format).
• Ability to work independently and within cross-functional teams in a fast-paced environment.
• Strong collaboration skills in a dynamic, matrixed environment to meet program milestones.
• Clear communication of regulatory strategy, risks, mitigations, and plans to project teams and senior management.
• Outstanding verbal and written communication; fluency in English required; knowledge of other European languages is a plus.
• Desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Benefits

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts for well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, holidays, volunteer days, sabbatical, and global recharge days
• 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.

About Moderna

Since 2010, Moderna aspires to build the leading mRNA technology platform and the infrastructure to reimagine how medicines are created and delivered, with a world-class team.

By living our mission, values, and mindsets every day, our people drive scientific progress and our culture, creating belonging and care for patients, employees, the environment, and 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.

Moderna champions in-person collaboration with a 70/30 in-office work model to foster innovation, teamwork, and mentorship. Join us in shaping a world where every interaction is an opportunity to learn and contribute.

If you want to make a difference and join a team changing the future of medicine, visit the Moderna careers site to learn about current opportunities: ModernaTX.com/careers

Moderna is a smoke-free, alcohol-free, and drug-free workplace.

Moderna is committed to equal opportunity in employment and non-discrimination for all applicants and employees regardless of race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or veteran status, genetic information, sexual orientation, marital or familial status, or any other characteristic protected by law. Qualified applicants will be considered regardless of criminal histories where permitted by law.

We value diverse experiences, backgrounds, and ideas and are committed to creating an environment where every employee can contribute their best. Moderna provides reasonable accommodations for applicants with disabilities. For accommodations, contact the Accommodations and Adjustments team at [e-mail].

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