Regional Regulatory Strategy

Description:

Moderna, a global leader in mRNA-based therapeutics, is seeking an experienced and motivated Manager, Regional Regulatory Strategist to join its expanding London office. This role presents an opportunity to be at the forefront of cutting-edge biotechnology, contributing to the advancement and regulatory success of Moderna’s innovative mRNA medicines across Europe and international markets.

As part of a fast-paced, collaborative, and mission-driven team, you will play a pivotal role in supporting the development and execution of regulatory strategies with the European Medicines Agency (EMA) and other international health authorities. Your expertise will directly influence how Moderna’s groundbreaking therapies reach patients around the world.

Key Responsibilities:

• Develop and implement regulatory strategies for assigned programs in the EU and international markets in collaboration with Global Regulatory Leads and Country Regulatory Teams.

• Prepare and contribute to regulatory submissions, including:

  • Scientific Advice meeting requests

  • Briefing documents

  • Clinical Trial Applications (CTAs)

  • Orphan Drug Designations (ODD)

  • Pediatric Investigation Plans (PIPs)

  • Expedited pathway applications

  • Development Safety Update Reports (DSURs)

  • Marketing Authorization Applications (MAAs)

• Coordinate submission activities to ensure alignment with global regulatory timelines and objectives.

• Manage interactions with the EMA and other health authorities to ensure compliance and facilitate efficient communication.

• Identify, assess, and mitigate regulatory risks associated with assigned programs.

• Track and archive regulatory correspondence, commitments, and feedback from agencies.

• Collaborate within cross-functional project teams, applying critical thinking and problem-solving skills to address regulatory challenges unique to mRNA-based medicines.

• Contribute to continuous improvement initiatives, optimizing regulatory processes and digital submission workflows.

Requirements:

• Degree in Life Sciences or related discipline (advanced degree such as PharmD, MSc, or PhD preferred).

• Minimum 5+ years of pharmaceutical industry experience with 3+ years focused on regulatory strategy.

• Strong familiarity with CTD format and regulatory submission content.

• In-depth understanding of EU and international regulatory legislation for drug development, product registration, and lifecycle management.

• Proven ability to manage multiple projects in a fast-paced environment with minimal supervision.

• Excellent collaboration, communication, and documentation skills.

• Strategic and analytical mindset with a passion for regulatory innovation and scientific advancement.

• Commitment to working within Moderna’s values of Boldness, Curiosity, Collaboration, and Relentlessness.

What Moderna Offers:

Moderna provides a comprehensive global benefits package designed to support your professional and personal wellbeing:

• Comprehensive health and insurance coverage

• Lifestyle Spending Accounts for flexible wellness options

• Free premium access to fitness, nutrition, and mindfulness programs

• Family planning and adoption benefits

• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and global recharge days

• Savings and investment programs

• Location-specific perks, employee engagement events, and recognition programs

About Moderna:

Founded in 2010, Moderna has built a pioneering mRNA technology platform that has redefined the boundaries of modern medicine. The company’s diverse pipeline spans infectious diseases, oncology, rare diseases, and cardiovascular disorders. Moderna is proud to be 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.

With a strong presence in London—one of the world’s most dynamic scientific hubs—Moderna is focused on delivering its life-changing mRNA products to patients and shaping the future of global healthcare.

Moderna operates under a 70/30 hybrid work model, ensuring a balance between in-person collaboration and flexibility, fostering innovation, mentorship, and teamwork.

Diversity, Equity & Inclusion Commitment:

Moderna is an equal opportunity employer dedicated to maintaining a diverse, inclusive, and equitable workplace. The company does not discriminate based on race, color, gender, identity, religion, national origin, disability, veteran status, or any other legally protected classification.

Qualified applicants with disabilities may request reasonable accommodation during the hiring process by contacting the Accommodations and Adjustments Team at:
📧 leavesandaccommodations@modernatx.com