Senior Director, Regulatory Project Management
ModernaTX, Inc.

The Role:

Managing a team of up to 14 Regulatory Project Managers, the Regulatory Project Management Lead will build, develop, and oversee a high-performing regulatory project management team. This individual will manage team members, provide strategic guidance, and ensure regulatory projects are executed efficiently and in compliance with global standards. In addition to hands-on project oversight, this role will enhance the project management framework, developing processes and best practices that support regulatory excellence and continuous improvement.

Here's What You'll Do:

Build and Develop Regulatory Project Management Capability:

• Establish a robust regulatory project management framework, incorporating industry best practices, tools, and processes.
  
• Design and implement training programs to enhance the team's project management skills and regulatory knowledge.
  
• Develop resource management and planning capabilities to support scalability and project efficiency across the organization.
  
• Resourcing model for deployment of RPMs to drug projects
  

Team Leadership and Line Management:

• Lead, mentor, and support a team of regulatory project managers, setting performance standards and development goals.
  
• Conduct regular performance evaluations, offering guidance and support for career growth and technical skill enhancement.
  
• Oversee resource allocation to balance team workloads and optimize project delivery.
  

Strategic Project Oversight:

• Guide the team in defining regulatory project strategies, ensuring alignment with company objectives and regulatory timelines.
  
• Oversee preparation and submission of regulatory filings (e.g., INDs, NDAs, MAAs) to ensure compliance and timely delivery.
  
• Serve as an escalation point for complex regulatory challenges, providing direction to project managers as needed.
  

Regulatory Compliance and Best Practice Implementation:

• Ensure adherence to FDA, EMA, ICH, and other global regulatory standards across all projects.
  
• Drive the implementation of best practices for regulatory project management, maintaining consistency and efficiency.
  
• Monitor regulatory landscape changes, updating team processes and training to align with evolving guidelines.
  

Stakeholder Engagement and Communication:

• Act as a liaison between the regulatory project management team and other departments, ensuring clear communication and optimal collaboration.
  
• Provide regular updates to senior management on project timelines, risks, and achievements.
  
• Lead cross-functional meetings to facilitate project progress and stakeholder alignment.
  

Continuous Improvement and Process Optimization:

• Identify and implement process improvements to enhance regulatory project management efficiency. Including identification of digital tools for RPM and submission efficiency and acceleration. (KPIs)
  
• Regularly review team performance metrics and outcomes, adjusting strategies as needed to improve efficiency and quality.
  
• Stay current with industry trends, sharing insights with the team to drive continuous improvement.
  

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

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
  
• Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry, including 3+ years in a leadership role.
  
• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
  
• Demonstrated experience in building and leading high-performing project management teams.
  
• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
  

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)

-

---