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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 is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.
We are on the lookout for a Senior Director, Global Regulatory Science (GRS) – Project Resilience Lead, who will play a pivotal role in spearheading the regulatory strategy and coordination of execution for Project Resilience across global sites such as the UK, Canada, Australia, and more. This vital position, based in Harwell, UK, is central to our mission of enhancing the production capabilities and distribution of mRNA-based therapeutics and vaccines. By joining us, you will be a key figure in bolstering the resilience of healthcare systems and ensuring direct access to rapid pandemic response capabilities.
Here's What You’ll Do:
Within 3 Months, You Will…
Develop and contribute to the consolidated regulatory deliverables plan for Project Resilience, integrating complex project facets into a cohesive strategy.
Initiate close collaboration with Country Regulatory Leads, ensuring the robustness and timeliness of regulatory plans and activities across various international markets.
Begin diligently maintaining the regulatory progress on the Project Resilience Global Score Card, ensuring all milestones and deliverables are accurately tracked and reported.
Within 6 Months, You Will…
Effectively communicate and present to management all relevant regulatory updates, requests, risks, and potential delays, ensuring transparent and timely information flow.
Identify and assess Project Resilience regulatory risks, coordinate and prepare risk registers, and devise corresponding mitigation plans, playing a key role in proactive risk management.
Support the execution of specific Project Resilience GRS deliverables such as coordinating Health Authority interactions, overseeing submission planning and approval tracking, and participating in cross-functional projects involving Quality, Manufacturing, and Site Leadership.
Within 12 Months, You Will…
Provide critical timeline updates to the GRS Leadership Team, proactively raising Project Resilience topics for endorsement, discussion, or decision, ensuring strategic alignment at all levels.
Prepare and deliver effective and influential communications and presentations tailored for both external and internal audiences, showcasing your strong communication acumen.
Work closely with the Executive Director of GRS Reg-CMC, the respective Resilience country affiliate Regulatory Heads, and facilitate meetings with government and regulatory officials in the Resilience countries, demonstrating leadership and diplomatic skills.
Here’s What You’ll Bring to the Table:
Degree in Life Sciences or related discipline, advanced degree preferred (PharmD, MSc, PhD).
12+ years of experience in the pharmaceutical industry; 8+ 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.
Self-starter with a high level of sense of accountability and ownership on assigned projects.
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.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been 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.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's 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 personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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