Senior Director, Regulatory Integration Lead (Respiratory Vaccines Unit) - Global Regulatory Sciences

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna is expanding its impact across Canada, anchoring in Toronto—Canada's largest city known for its vibrant biotech innovation. Our offices in Toronto focus on commercial operations, bringing our innovative mRNA products to the Canadian market. By joining our team, you will be at the forefront of transforming medicine and building a resilient future in biotech and healthcare innovation, contributing to Canada’s leadership in global health.

We are seeking a Senior Director Regulatory Integration Lead within our Respiratory Vaccines Unit. In this role, you will support integration across programs, functions, and geographies to align regulatory strategies for respiratory vaccines, bridging global regulatory product development with local manufacturing site regulatory activities. As a strategic partner to the Head of Regulatory for the Respiratory Vaccines Unit, you will be instrumental in guiding cross-functional initiatives and driving alignment across regulatory functions. This role is ideal for an experienced regulatory professional dedicated to advancing global health through strategic planning and collaboration.

Here's What You'll Do:

Your key responsibilities will be:

• Shape and execute regulatory strategies for the respiratory vaccines portfolio, encompassing both single-component and combination respiratory vaccines.
• Drive alignment across regulatory functions, including regulatory strategy, CMC, operations, and labeling, to meet organizational goals.
• Lead high-impact strategic initiatives, ensuring cross-functional integration aligns with Moderna’s broader corporate objectives.

Your responsibilities will also include:

• Serve as a liaison between Regulatory Affairs and Commercial to ensure that regulatory goals align with business strategies and provide insights into long-range forecast planning.
• Facilitate collaboration between global and local teams to synchronize regulatory submissions with product development and manufacturing timelines.
• Act as the primary point of contact for the Respiratory Vaccines Unit at the Canadian manufacturing site, ensuring seamless integration and communication.
• Manage stakeholder relationships by coordinating high-level regulatory meetings, preparing executive-level reports, and briefing senior leadership on regulatory priorities.

The key Moderna Mindsets you’ll need to succeed in the role:

• Act with urgency: This role demands swift and strategic action to maintain Moderna’s leadership in vaccine development, emphasizing timely regulatory integration to address global health needs.
• Prioritize the platform: You will contribute to aligning regulatory efforts with Moderna’s platform-centric approach, ensuring that each product supports the broader mission to improve health outcomes worldwide.

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 offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

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 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. 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 or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment 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 and Adjustments team at leavesandaccommodations@modernatx.com.

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