Associate Director, Regulatory Strategy & Global Resilience Initiatives page is loaded

Associate Director, Regulatory Strategy & Global Resilience Initiatives

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
• Savingsandinvestments
• 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 our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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 committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com .

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About Us

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.