Senior Director, Regulatory Integration Lead (Respiratory Vaccines Unit) - Global Regulatory Sciences at ModernaTX, Inc. in Cambridge, Massachusetts

Job Description:

The Role:



Moderna is a global leader in vaccine development, dedicated to advancing innovative solutions for respiratory infectious diseases. We are seeking a Senior Director Regulatory Integration Lead within Respiratory Vaccines Unit to support the integration across programs, functions and geographies of the regulatory strategy for respiratory vaccines and provide high-level coordination between global regulatory product development and local manufacturing site regulatory activities.


The Senior Director Regulatory Integration Lead will serve as a strategic partner to the Head of Regulatory Respiratory Vaccines Unit. This individual will focus on strategic planning and execution, competitive intelligence & product labeling, cross-functional leadership and collaboration, and communication.


As Senior Director Regulatory Integration Lead, you will play a critical role in shaping and executing the regulatory strategy across a portfolio of respiratory vaccine programs. Reporting directly to the VP Regulatory for the Respiratory Vaccines Unit, this role is designed for an experienced regulatory professional to lead strategic initiatives that bridge global regulatory product development with local regulatory and manufacturing site activities.



Here's What You'll Do:




Strategic Planning & Execution:

• Support the Head of RV Unit to shape and implement regulatory strategies for the respiratory vaccines portfolio, focusing on both single-component and combination respiratory vaccines.
  
  


• Ensure strategic alignment across regulatory functions (regulatory strategy, CMC, operations, labeling) with organizational goals.
  
  


• Lead high-level strategic initiatives across the regulatory function, driving cross-functional integration with broader corporate objectives.
  
  

Cross-functional Leadership & Collaboration:

• Serve as a liaison between regulatory affairs and Commercial ensuring that regulatory goals are in line with overall business strategies, and providing relevant input into the long range forecast planning.
  
  


• Facilitate collaboration between global and local teams to align regulatory submissions with product development and manufacturing schedules.
  
  


• Serves as the Respiratory Vaccines Unit point of contact for the Canadian manufacturing site
  
  

Stakeholder Management & Communication:

• Ensure effective communication between the regulatory affairs team and internal stakeholders, providing regular updates on regulatory activities, timelines, and strategic priorities.
  
  


• Prepare executive-level reports, presentations, and briefings for senior leadership.
  
  


• Coordinate high-level regulatory meetings, ensuring preparedness and follow-up on key actions.
  
  

Here's What You'll Need (Minimum Qualifications):

• Education: Bachelor's degree in Regulatory Affairs, Life Sciences, or a related field; an advanced degree (e.g., MS, Ph.D., PharmD, MBA) is preferred.
  
  


• Experience: Minimum 10 years in the pharmaceutical or biotech industry, with at least 5 years focused on regulatory affairs within vaccines or infectious diseases.
  
  


• Leadership: Proven ability to lead cross-functional teams, aligning regulatory strategy with corporate and manufacturing goals.
  
  


• Analytical & Communication Skills: Demonstrated experience in preparing executive-level reports, with strong communication and analytical skills to convey regulatory priorities effectively.
  
  

Here's What You'll Bring to the Table (Preferred Qualifications):

• Advanced Degree: Master's, Ph.D., or PharmD in Regulatory Affairs or a related field.
  
  


• Cross-functional Collaboration: Experience working across regulatory strategy, commercial, and manufacturing functions.
  
  


• Strategic & Competitive Insight: Proven ability to incorporate competitive intelligence and long-range planning into regulatory strategy.
  
  

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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