Senior Manager, Regional Regulatory Project Management

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 solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines.

As the Sr. Manager of Regulatory Projects, you will provide forward-thinking leadership in overseeing the strategic and operational aspects of regulatory projects across the organization. Acting as a strategic partner, you will guide the development and execution of global regulatory plans that align with long-term business goals. This role requires a motivated, experienced Regional Regulatory Project Manager with the ability to lead complex projects, manage international regulatory strategies, and navigate diverse regulatory landscapes. Your expertise will ensure timely and compliant regulatory submissions, driving Moderna’s impact in multiple international markets.

Here's What You’ll Do:

Your key responsibilities will be:

• Lead and manage cross-functional teams to ensure the successful and timely completion of regulatory submissions and approvals.

• Develop and oversee project plans, encompassing timelines, milestones, resources, and budgets, to facilitate efficient regulatory approval processes.

• Monitor project progress, addressing deliverables, potential roadblocks, and delays effectively.

• Analyze regulatory requirements across jurisdictions and provide actionable guidance to internal stakeholders.

Your responsibilities will also include:

• Manage the preparation, submission, and approval of regulatory documentation for international markets (EMA, MHRA, etc.).

• Coordinate with regulatory bodies, consultants, and vendors to streamline submission and approval processes.

• Ensure the accuracy, completeness, and consistency of regulatory documents and submissions.

• Collaborate with cross-functional teams, including R&D, legal, marketing, quality assurance, and clinical affairs, to align regulatory requirements with product development and marketing strategies.

• Maintain regulatory records and files, ensuring compliance with internal and external standards.

• Promote continuous improvement by identifying efficiencies in regulatory processes and sharing best practices across the organization.

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

• Prioritize the platform: Emphasize alignment with Moderna’s platform-oriented approach, ensuring that regulatory projects reinforce our overarching mission to drive impactful health outcomes.

• Pursue options in parallel: Use a flexible approach to explore and integrate multiple regulatory pathways, enhancing our ability to meet global compliance efficiently.

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

• Bachelor’s degree with minimum of 7 years of experience leading regulatory submissions and or strong program management experience in a hands-on and strategic capacity.

• Proven ability to act as a forward-thinking leader, capable of planning ahead and identifying strategic pathways in regulatory operations.

• Extensive cross-functional project management experience, with a track record of making progressive and impactful decisions.

• Strong understanding of drug development, clinical study processes, and regulatory submissions, with the ability to address both the day-to-day and long-term strategic aspects.

• Expertise in ensuring compliance with cGMP and managing complex regulatory submissions across global markets.

• Demonstrated ability to lead teams effectively, manage multiple complex projects simultaneously, and contribute to the broader strategic direction of the organization.

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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