• Job Description

  Req#: R17180

  The Role:
  Moderna Therapeutics is seeking an Associate Director, Regulatory Project Management to support development and registration programs within the Respiratory Vaccines Franchise. This role is designed for an experienced and forward-thinking regulatory project manager who thrives in a fast-paced, innovative environment and can seamlessly integrate strategy with operational execution across all stages of product development, registration, and post-marketing.

  As a key member of the Global Regulatory Science team, you will partner closely with Global Regulatory Leads to develop and execute comprehensive regulatory strategies for the U.S. and ex-U.S. markets. You will lead the development of proactive global regulatory plans that articulate clear milestones, highlight risks and opportunities, and support timely regulatory decision-making.

  This is a highly visible, cross-functional role requiring strong leadership, agility, and strategic foresight. You will be accountable for driving regulatory excellence by aligning cross-functional stakeholders, managing complex timelines, and anticipating challenges to enable the successful delivery of regulatory milestones that support Moderna’s mission to bring transformative mRNA medicines to patients worldwide.

  
  Here’s What You’ll Do:

  • Serve as a strategic thought partner to Global Regulatory Leads by developing forward-looking, globally aligned regulatory plans for late-stage respiratory vaccine programs.

  • Identify and propose innovative regulatory pathways to support efficient planning, enable informed decision-making, and align with global regulatory expectations and business objectives.

  • Lead the hands-on execution of regulatory plans, ensuring alignment between tactical operations and broader strategic objectives across global development stages.

  • Collaborate closely with cross-functional teams and senior leadership to ensure clarity on regulatory deliverables, timelines, and interdependencies.

  • Facilitate routine and ad hoc project review meetings, providing high-value insights to inform decision-making, mitigate risk, and capitalize on regulatory opportunities.

  • Troubleshoot complex operational challenges and implement scalable, strategic solutions to improve process efficiency and submission readiness.

  • Champion a culture of continuous improvement, leveraging lessons learned, industry trends, and digital tools to evolve regulatory project management practices.

  • Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress into actionable business insights.

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

  • BA/BS degree in a scientific, engineering, or healthcare discipline required; advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred.

  • Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory project or program management.

  • Proven ability to lead regulatory planning and execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities.

  • Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-US) regulations and agency expectations.

  • Demonstrated leadership in managing complex regulatory deliverables across cross-functional teams within a matrixed organization.

  • Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy.

  • Experience supporting respiratory vaccine development is highly desirable.

  • Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and present it to senior leadership and global stakeholders.

  • Adept at managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight.

  • Exceptional in leveraging project management tools, and best practices to enhance efficiency and alignment.

  • Committed to continuous learning and improvement, bringing an innovation mindset to regulatory execution and cross-functional collaboration.

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

  • Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Lifestyle Spending Accounts to personalize your well-being journey
  • Family planning and adoption benefits
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities
  • Location-specific perks and extras

  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.

  Our Working Model

  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.

  Moderna is a smoke-free, alcohol-free, and drug-free work environment.

  Equal Opportunities

  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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

  Accommodations

  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 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 contact the Accommodations team at leavesandaccommodations@modernatx.com .

  Export Control Notice

  This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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• About the company

  091 Moderna, Inc., is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines.

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