Manager, Regional Regulatory Strategist

Overview

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 are seeking talents who are ready to contribute to our mission and transform the landscape of health worldwide.

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.

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What You’ll Do:

Responsibilities are focused on developing and executing regulatory strategy for EU and international markets, in collaboration with Global Regulatory Leads, Regional Regulatory Strategists, and Country Regulatory Leads. Key tasks include preparing and contributing to regulatory submissions and coordinating timelines.

• 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

Your responsibilities will also include:

• 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

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

• We question convention because proven models don’t always fuel the future. In this role, you will be navigating the complexities of novel mRNA modalities, which require a departure from traditional regulatory paradigms. Embracing unconventional thinking will empower you to shape and…