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’s Project Resilience encompasses the construction and operationalization of in-country pharmaceutical manufacturing sites dedicated to producing commercial mRNA vaccines. The scope of Project Resilience involves constructing facilities that adhere to stringent regulatory standards, qualifying the manufacturing processes and equipment to ensure they meet the necessary quality and safety requirements, obtaining facility licensure within the region, and obtaining the necessary regulatory approvals.

Project Resilience aims to enhance the production capabilities and distribution of mRNA-based therapeutics and vaccines, thereby bolstering the resilience of healthcare systems by ensuring direct access to rapid pandemic response capabilities and access to Moderna’s vaccines in development for critical vaccines and therapeutics.

This role will lead the execution of the regulatory deliverables for Project Resilience across all sites (e.g., UK, Canada, Australia, etc.). This role requires an understanding of the various development and registration activities in the local Resilience countries and awareness of the interdependencies of the Portfolio timelines as well as the Resilience manufacturing site timelines.

Here’s What You’ll Do:

Your key responsibilities will be:

• Contribute to the consolidated regulatory deliverables plan for Project Resilience.

• Work closely with the Country Regulatory Leads in the Project Resilience markets to ensure the robustness and timeliness of regulatory plans, and the execution and coordination of the overall GRS activities for Project Resilience among GRS line functions at the HQ, regional, and country levels.

• In collaboration with GRS HQ and Country Regulatory Leads, identify and assess Project Resilience regulatory risks, coordinate and prepare risk register, potential delays and corresponding mitigation plans.

• Coordinate regulatory activities with external partners and stakeholders, ensuring alignment and compliance with local and international regulations.

• Assist in preparation of regulatory documents and applications to Health Authorities, ensuring accuracy, completeness, and timeliness.

Your responsibilities will also include:

• Provide timeline updates to GRS LT and raise Project Resilience topics relevant for endorsement, discussion, or decision.

• Prepare and deliver effective communications and presentations for external and internal audiences.

• Integrate and manage the UK-specific aspects of the role, ensuring 40-50% of the responsibilities are focused on UK-specific regulatory activities and 50% on the integration of Resilience sites to consolidate best practices and processes.

• Mentor and guide junior regulatory staff, fostering a collaborative and high-performance culture within the regulatory team.

• Monitor regulatory developments and trends that may impact Project Resilience, advising on necessary adjustments to strategies and plans.

• Ensure all regulatory activities are conducted in accordance with Moderna’s policies, SOPs, and ethical standards.

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

• Prioritize the platform: Ensuring that the strategic goals of Project Resilience align with the overarching objectives of Moderna’s platform.

• Act with urgency: Rapidly addressing regulatory challenges and making swift decisions to keep Project Resilience on track.

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

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

• 8+ years of experience in the pharmaceutical industry; 5+ years of experience in Global Regulatory CMC strategy.

• Good knowledge of current international regulations related to GMP manufacturing, licensing, and overall quality principles for innovative medicines, including mRNA technology and gene therapy requirements.

• Experience and good understanding of Module 3 content of regulatory submissions.

• Experience with manufacturing process tech transfers and registration of new manufacturing sites.

• Strong project management and analytical skills.

• Ability to bring together various stakeholders and to reconcile different perspectives and priorities.

• Ability to work independently to manage multiple projects in a fast-paced environment.

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.

• Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.

• A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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.