Manager, Regional Regulatory Strategist Job at Moderna (London)

Job Description

As a Manager, Regional Regulatory Strategist, you will play a critical role in advancing the global regulatory path for Moderna’s mRNA programs in the European Union and international markets. This role is designed for a forward-thinking and agile regulatory professional who thrives in a fast-paced, innovation-driven environment. You will support the development and execution of regulatory strategy with the EMA and other international health authorities, ensuring scientific, strategic, and operational excellence throughout the product lifecycle. Your work will contribute directly to enabling cutting-edge mRNA medicines to reach patients worldwide by facilitating health authority interactions, managing submission timelines, and mitigating regulatory risk. This is a pivotal position for someone looking to be at the frontier of regulatory science while gaining exposure to evolving global frameworks, complex filings, and international regulatory pathways. This individual contributor role, based in our London office, places you at the intersection of regulatory leadership and scientific advancement.

Job Responsibility

Supporting the development and execution of regulatory strategy for assigned programs in the EU and international markets in collaboration with Global Regulatory Leads, Regional Regulatory Strategists, and Country Regulatory Leads
Preparing and contributing to regulatory submissions including Scientific Advice meeting requests, briefing documents, clinical trial applications, orphan drug designations, pediatric plans, expedited pathway applications, DSURs, and marketing authorization applications (MAA)
Coordinating aspects of regulatory submissions relevant to the assigned program(s), ensuring alignment with global strategy and timelines
Supporting regulatory interactions with the EMA and other international health authorities
Engaging with cross-functional regulatory teams to ensure consistency, compliance, and strategy execution
Identifying, assessing, and managing regulatory risks associated with assigned program(s)
Tracking, following up, and archiving correspondence, regulatory commitments, and queries from EMA and international agencies
Working independently and collaboratively in matrixed project teams to achieve program goals
Applying critical thinking to anticipate potential regulatory hurdles and proactively address challenges specific to mRNA as a novel modality
Contributing to continuous improvement and innovation within regulatory processes

Requirements

Degree in Life Science or related discipline, advanced degree preferred (PharmD, MSc, PhD)
5+ years of experience in the pharmaceutical industry. 3+ years of experience in Regulatory strategy
Strong experience with CTD format and content of regulatory filings
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance in the EU and/or relevant International markets
Ability to work independently to manage multiple projects in a fast-paced environment
Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
Outstanding communication skills (verbal and written)
A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

What we offer

Best-in-class healthcare, plus voluntary benefit programs
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
Location-specific perks and extras

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Manager, Regional Regulatory Strategist

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