The Role:

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 Harwell, a global hub for scientific advancement in the UK. Our Harwell office will be home to roles critical to our mission of delivering mRNA medicines to patients worldwide. Join us at this exciting location where you’ll help shape the future of healthcare innovation in one of the UK’s most dynamic science and technology campuses.

This role is central to Moderna’s global regulatory success. As Associate Director, Global Regulatory Science – CMC, you will lead regulatory CMC strategy and execution for one or more mRNA programs. You will be instrumental in developing global strategies and ensuring that regulatory submissions are flawlessly executed across the product lifecycle, including pre- and post-approval phases. You’ll collaborate closely with Manufacturing, Quality, and Analytical Development groups to guide regulatory compliance and shape submissions that meet both scientific rigor and business needs. You’ll also be responsible for preparing key regulatory documents and leading Health Authority interactions. This role requires a technically strong, action-oriented leader who thrives in fast-paced environments and is eager to contribute to Moderna’s transformative impact on patient care through mRNA technology.

Here’s What You’ll Do:

Your key responsibilities will be:

• Developing and implementing regulatory CMC strategies for global IND/CTA/BLA/MAA submissions, covering both new applications and post-approval filings.

• Leading regulatory CMC input for quality and manufacturing activities, with a focus on risk identification and mitigation.

• Preparing and overseeing the submission of CMC and Quality-related documents to global Health Authorities.

• Driving Health Authority interactions and ensuring alignment between internal teams and external expectations.

• Guiding stakeholders on regulatory implications of changes to process, manufacturing, or analytical controls.

Your responsibilities will also include:

• Reviewing submission documents for readiness, ensuring compliance with global regulatory standards.

• Advising Quality, Manufacturing, and Development teams on regulatory directives, guidance, and emerging changes.

• Participating in the design and upkeep of regulatory tools, processes, and CMC submission templates.

• Assessing and interpreting change controls for regulatory impact.

• Supporting cross-functional collaboration and embedding a global regulatory mindset into CMC initiatives.

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

• “We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”
  You will operate at the cutting edge of regulatory science, navigating global regulatory environments while rapidly absorbing emerging CMC guidance and translating it into actionable strategy.

• “We digitize everywhere possible using the power of code to maximize our impact on patients.”
  Your work will be amplified by digital tools and data-driven systems. Embracing Moderna’s commitment to digital innovation, you’ll contribute to modernizing regulatory operations while staying close to breakthroughs in Generative AI.

Here’s What You’ll Bring to the Table:

• BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required

• 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

• 5+ years of experience in Biologics- and/or Vaccines-focused Regulatory CMC

• Direct experience and strong knowledge of current global CMC regulations, including CTD format and content of CMC regulatory submissions

• Knowledge of and broad experience with regulatory procedures related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM)

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones

• Ability to work independently

• Exceptional written and oral communication

• As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• 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!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.