Regional Regulatory Manager

About the Role:

As a Regional Regulatory Manager, you will play a pivotal role in shaping the global regulatory strategy for our client's mRNA programs across the European Union and international markets. This position is ideal for a forward-thinking, agile regulatory professional who thrives in a dynamic, innovation-driven environment. You will help guide the regulatory pathway for cutting-edge mRNA medicines, ensuring scientific rigor, strategic alignment, and operational excellence throughout the product lifecycle.

In this individual contributor role, based in our London office, you will be at the forefront of regulatory science, managing complex filings, interacting with global health authorities, and contributing to the successful delivery of transformative therapies to patients worldwide.

Key Responsibilities:

• Develop and implement regulatory strategies for assigned programs in the EU and international markets, collaborating closely with Global Regulatory Leads, Regional Regulatory Strategists, and Country Regulatory Leads.

• Prepare and contribute to regulatory submissions, including Scientific Advice requests, briefing documents, clinical trial applications, orphan drug designations, paediatric plans, expedited pathway applications, DSURs, and marketing authorization applications (MAAs).

• Coordinate regulatory submission activities, ensuring alignment with global strategies and timelines.

• Support regulatory interactions with the EMA and other international health authorities.

• Collaborate with cross-functional teams to ensure regulatory consistency, compliance, and strategic execution.
• Identify, assess, and manage regulatory risks associated with assigned programs.

• Track, follow up, and archive correspondence, commitments, and queries from EMA and international agencies.

• Work independently and collaboratively within matrixed project teams to achieve program objectives.

• Apply critical thinking to anticipate potential regulatory challenges and proactively address hurdles unique to mRNA as a novel modality.

• Contribute to continuous improvement and innovation within regulatory processes.