Associate Director, Regulatory Project Management at ModernaTX, Inc. in Cambridge, Massachusetts

Job Description:

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.
  
  

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options


• Flexible Spending Accounts for medical expenses and dependent care expenses


• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities


• Family care benefits, including subsidized back-up care options and on-demand tutoring


• Free premium access to fitness, nutrition, and mindfulness classes


• Exclusive preferred pricing on Peloton fitness equipment


• Adoption and family-planning benefits


• Dedicated care coordination support for our LGBTQ+ community


• Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary year-end shutdown
  • Paid sabbatical after 5 years; every 3 years thereafter


• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents


• 401k match and Financial Planning tools


• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options


• Complimentary concierge service including home services research, travel booking, and entertainment requests


• Free parking or subsidized commuter passes


• 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.


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 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)


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