Director, Global Regulatory Labeling Strategy

Moderna; City Of London; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

A leading biotechnology company in London is seeking a Director for Global Regulatory Labeling Strategy. This role involves developing regulatory-compliant labeling across multiple international markets including the US, EU, UK, and Switzerland. You will lead the creation of labeling content and engage in cross-functional collaboration. The ideal candidate has over 10 years of experience in the pharmaceutical industry and a strong background in regulatory processes.

Benefits

Quality healthcare and insurance benefits

Lifestyle Spending Accounts

Free fitness classes

Generous paid time off

Qualifications

• 10+ years of experience in the pharmaceutical industry.
• 7+ years of experience in regulatory labeling.
• Experience in rare diseases, oncology, and/or vaccines is desirable.

Responsibilities

• Lead development of Target Label Profiles for early-phase assets.
• Drive creation and accountability of regulatory labeling content.
• Maintain up-to-date knowledge of global labeling regulations.

Skills

Leadership

Communication

Regulatory compliance

Medical/technical writing

Collaboration

Education

BA/BS in a scientific discipline

Master’s or PhD (preferred)

Tools

CTD format

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 across diseases. You will contribute to a growing organization, collaborating with exceptional colleagues and strategic partners worldwide on global health initiatives. Moderna is expanding in London (focus on commercial operations for the UK market) and may offer the role based in Harwell (state-of-the-art facility for mRNA research, development, and manufacturing). Moderna is seeking a Director, Global Regulatory Labeling Strategy to support a growing pipeline. The role is based in the UK (London or Harwell) and is for a regulatory professional prepared to deliver regulatory-compliant labeling for a global product portfolio across the United States, European Union, United Kingdom, and Switzerland.

This is an individual contributor role with deep cross-functional collaboration and exposure to cutting-edge regulatory processes. There are opportunities to engage with data-driven technologies and explore intersections with Generative AI tools as they evolve within regulatory work.

Responsibilities

Here’s What You’ll Be Doing:

• Lead the development of Target Label Profiles (TLPs) for early-phase assets, ensuring strategic alignment with clinical and regulatory goals.

• Drive the creation and accountability of regulatory labeling content for marketing applications (MAAs) and all related supplements and amendments.

• Develop high-quality labeling that adheres to regulatory requirements and global standards, serving as the subject matter expert for US, EU, UK, and Swiss markets.

• Own the regulatory review and content development for product artwork, including trade names, established names, logos, and graphics.

• Interface with cross-functional project teams to embed labeling considerations early and ensure consistent compliance with the Company Core Data Sheet (CCDS).

Your responsibilities will also include:

• Maintain up-to-date knowledge of evolving global labeling regulations and industry trends; proactively communicate implications to stakeholders.

• Communicate labeling strategies, risk mitigations, and implementation plans clearly to Project Development Teams, Global Regulatory Science Leadership, and senior stakeholders.

• Act as a thought leader within the regulatory labeling community, representing Moderna in external forums and maintaining strategic awareness of industry shifts.

• Provide flexible labeling support across the portfolio, offering coverage for other products during peak workload or team member absences.

• Contribute to the definition and improvement of the end-to-end global labeling process within the regulatory function.

Moderna Mindsets

• We question convention because proven models don’t always fuel the future. In this role, you’ll be challenged to innovate beyond traditional labeling strategies, especially as you navigate complex multi-region regulations. You’ll be expected to offer bold, data-informed solutions that move faster than standard industry timelines.

• We digitize everywhere possible using the power of code to maximize our impact on patients. You will be well positioned to explore and implement digital tooling to optimize labeling operations, and may contribute to early-stage exploration of Generative AI in labeling workflows and content generation, contributing to broader automation goals.

What You’ll Bring

• Experience facilitating meetings and driving consensus and results.

• Excellent leadership, communication (verbal and written) and collaboration skills.

• Proven ability in medical/technical writing.

• Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.

• Sense of urgency regarding regulatory communications and response timelines to support product approvals and labeling negotiations.

• Integrity and high standards for self and others.

• Results orientation and strategic thinking to link company and departmental visions with daily work.

• Ability to interact effectively as a member of the Regulatory sub-team and collaborate with partners, including affiliates and third parties.

• Flexibility/adaptability to work with diverse teams and situations.

• Relationship building, teamwork and cooperation to maintain strong working relationships.

Qualifications

• BA/BS in a scientific discipline required; Master’s or PhD preferred.

• 10+ years of experience in the pharmaceutical industry

• 7+ years of experience in Regulatory labeling

• Strong knowledge of artwork development, review and approval.

• Strong knowledge of current global regulations, including vaccine development regulations and registrations pathways.

• Strong experience with CTD format and regulatory filings.

• Exceptional written and oral communication.

• Experience dealing with a broad range of stakeholders internal and external to the company.

• Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.).

Benefits

• Quality healthcare and insurance benefits

• Lifestyle Spending Accounts to support 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, and discretionary time off

• 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 world-class team to reimagine how medicines are created and delivered. We strive to give our people a platform to change medicine and the world.

By living our mission, values, and mindsets, our people drive scientific progress and create a culture of belonging that cares for patients, employees, the environment, and communities. We are 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. This structure fosters innovation, teamwork, and mentorship. Join us to shape 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, please visit the careers page to learn more about current opportunities.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

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

Moderna is committed to offering reasonable accommodations for qualified job applicants with disabilities. For accommodations in the hiring process, please contact the Accommodations and Adjustments team at [e-mail].