Senior Manager Regional Regulatory Project Management

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives. Modernas 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 Modernas global business operations. Were 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 forwardthinking 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 of global regulatory plans that align with longterm 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 Modernas impact in multiple international markets.

Heres What Youll Do:

Your key responsibilities will be:

• Lead and manage crossfunctional 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 crossfunctional 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 youll need to succeed in the role:

• Prioritize the platform: Emphasize alignment with Modernas platformoriented 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.

Heres What Youll Bring to the Table:

• Bachelors degree with minimum of 7 years of experience leading regulatory submissions and or strong program management experience in a handson and strategic capacity.

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

• Extensive crossfunctional 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 daytoday and longterm 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.

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to wellbeing
• 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 global recharge days and a discretionary yearend shutdown
• Savingsandinvestments
• Locationspecific 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 theinfrastructure to reimagine how medicines are created and delivered and a worldclass 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 peopleare 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 opportunity in employment and nondiscrimination for all employees and qualified applicants without regard to a persons 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 consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation 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 .