Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory strategies for innovative mRNA projects and ensure compliance across global sites.
- Company: Join Moderna, a trailblazer in mRNA technology, transforming medicine and global health.
- Benefits: Enjoy flexible work options, generous time off, wellness resources, and a vibrant company culture.
- Why this job: Be part of a mission-driven team making a real impact on healthcare and patient lives.
- Qualifications: Requires a degree in Life Sciences and 8+ years in pharmaceutical regulatory strategy.
- Other info: Embrace a collaborative environment with a focus on mentorship and professional growth.
The predicted salary is between 48000 - 84000 £ per year.
Social network you want to login/join with:
Associate Director, Regulatory Strategy & Global Resilience Initiatives, Oxford
col-narrow-left
Client:
Moderna
Location:
Oxford, United Kingdom
Job Category:
Other
–
EU work permit required:
Yes
col-narrow-right
Job Reference:
4c0952ad7c8a
Job Views:
7
Posted:
12.08.2025
Expiry Date:
26.09.2025
col-wide
Job Description:
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.
#J-18808-Ljbffr
Associate Director, Regulatory Strategy & Global Resilience Initiatives employer: Moderna
Contact Detail:
Moderna Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Regulatory Strategy & Global Resilience Initiatives
✨Tip Number 1
Familiarise yourself with the latest developments in mRNA technology and regulatory frameworks. This will not only help you understand the role better but also allow you to engage in informed discussions during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in regulatory strategy. Attend relevant conferences or webinars to make connections that could provide insights or referrals for your application.
✨Tip Number 3
Stay updated on global health initiatives and how they relate to regulatory strategies. Being knowledgeable about current events can help you demonstrate your passion for the field and your alignment with Moderna's mission.
✨Tip Number 4
Prepare to discuss specific examples of how you've managed regulatory challenges in past roles. Highlighting your problem-solving skills and ability to work under pressure will show that you're ready for the fast-paced environment at Moderna.
We think you need these skills to ace Associate Director, Regulatory Strategy & Global Resilience Initiatives
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Associate Director, Regulatory Strategy & Global Resilience Initiatives at Moderna. Make sure you understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 8+ years of experience in the pharmaceutical industry, particularly in Global Regulatory CMC strategy. Provide specific examples of how your past roles align with the responsibilities outlined in the job description.
Showcase Your Skills: Make sure to highlight your project management and analytical skills, as well as your ability to collaborate in a dynamic environment. Use concrete examples to demonstrate how you've successfully managed multiple projects or led teams in the past.
Craft a Compelling Cover Letter: Write a tailored cover letter that not only outlines your qualifications but also expresses your enthusiasm for Moderna's mission and values. Mention how you can contribute to Project Resilience and the overall goals of the company.
How to prepare for a job interview at Moderna
✨Understand the Regulatory Landscape
Familiarise yourself with the current international regulations related to GMP manufacturing and licensing, especially those relevant to mRNA technology. This knowledge will help you demonstrate your expertise and readiness to tackle regulatory challenges during the interview.
✨Showcase Project Management Skills
Be prepared to discuss your project management experience, particularly in coordinating complex regulatory activities. Highlight specific examples where you've successfully managed timelines and stakeholder expectations, as this role requires strong organisational skills.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since the role involves preparing presentations and communications for various audiences, showcasing your communication skills will be crucial. Consider preparing a brief presentation on a relevant topic to demonstrate your ability.
✨Demonstrate Collaborative Spirit
Emphasise your ability to work in cross-functional teams and reconcile different perspectives. Share examples of how you've successfully collaborated with diverse stakeholders in previous roles, as this will resonate well with Moderna's emphasis on teamwork and collaboration.
