Associate Director, Regulatory Project Management

The Role:
As an Associate Director of Regulatory Projects, you will be a forward-thinking  leader, driving both the strategic  and operational  aspects of global regulatory projects. Acting as a key strategic  partner, you will develop proactive regulatory plans, identify innovative pathways to success, and make decisive, progressive decisions that align with broader organizational goals.

In this role, you will be hands-on in managing day-to-day  project execution, while maintaining a clear focus  on the bigger picture to ensure regulatory milestones are achieved.

Here’s What You’ll Do:

• Serve as a strategic  partner by leading the development of forward-looking global regulatory plans for ongoing late-stage programs.

• Identify innovative regulatory pathways to expedite project timelines and ensure alignment with business objectives.

• Drive decisive and progressive decision-making in regulatory strategies, ensuring timely delivery and risk mitigation.

• Manage the execution of regulatory plans with both a hands-on approach and an appreciation for the broader strategic  impact of decisions.

• Collaborate with cross-functional teams and senior management to align on project objectives and ensure timely submission of regulatory documents.

• Lead regular status review meetings, providing strategic  insights  to address project risks

• and opportunities.

• Proactively troubleshoot operational  issues and implement  strategic  interventions to optimize regulatory processes.

• Promote a culture of continuous improvement, driving efficiencies and innovative approaches to regulatory project management.

• Develop and present strategic  reports and dashboards to senior leadership on project performance and regulatory outcomes.

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

• Bachelor’s degree with minimum  of 5 years of experience in leading regulatory submissions and or strong program management experience

• Proven track record of being a forward-thinking  planner with a strong ability to balance hands-on project execution with strategic  decision-making.

• Cross-functional project management experience in the pharmaceutical or biotechnology industry.

•  Strong understanding of the regulatory submission process, cGMP requirements, and experience in identifying regulatory pathways for accelerated timelines.

• Ability to manage multiple projects  simultaneously, ensuring strategic  alignment and delivery within scope and deadlines.

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 b