Submission Manager, Regulatory Operations
Moderna
The Role:
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.
Moderna is strengthening its international business services hub in Warsaw, supporting our growing global operations. We welcome professionals ready to help advance our mission and shape the future of mRNA medicines.
In this role, you will sit at the center of global regulatory operations, orchestrating the planning, management, and execution of complex submission strategies.
You will partner closely with Regulatory Leads and cross-functional teams to deliver high-quality submissions to health authorities worldwide, ensuring precision, compliance, and speed.
This is a highly visible individual contributor role where your expertise will directly influence the success of global regulatory filings and lifecycle management.
Here's What You'll Do:
Manage the development and maintenance of comprehensive submission content plans, tracking documents from authoring through approval, publishing, and quality control.
Serve as the global submissions' expert, guiding teams on e-submission standards (eCTD, NeeS, etc.) and lifecycle management, while clearly communicating regional regulatory differences.
Partner with Regulatory Leads to plan and prepare high-quality global submissions, executed internally or through CROs, ensuring timely delivery to global health authorities.
Provide clear communication of project status, risks, timelines, and milestones to stakeholders and senior management.
Deliver operational oversight across the full submission lifecycle, including planning, preparation, publishing, validation, and submission of INDs, NDAs, MAAs, amendments, updates, and variations.
Manage external publishing vendors to ensure the creation and timely delivery of high-quality regulatory submission packages.
Maintain deep technical expertise in evolving regulatory requirements, ensuring alignment with internal processes and external expectations.
Act as a subject matter expert for Moderna’s document management systems, driving efficient and compliant document workflows.
Compile and coordinate regulatory submissions, ensuring accurate and timely distribution to health authorities and CRO partners.
Oversee submission and product lifecycle information, ensuring data integrity and accessibility across systems.
Lead and contribute to special projects, bringing operational excellence and continuous improvement to regulatory processes.
Act as the primary point of contact for major submissions, providing guidance, structure, and leadership across submission teams.
Drive urgency in execution, ensuring all submissions meet critical global health authority deadlines.
Leverage digital tools and platforms to enhance submission efficiency, quality, and scalability, including opportunities to work closely with emerging generative AI-enabled solutions in regulatory operations.
The key Moderna Mindsets you’ll need to succeed in the role:
We act with urgency: Your timely management of submissions will be critical to meeting global health authorities' deadlines.
We prioritize the platform: Utilizing digital tools and systems will enhance submission efficiency and accuracy.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
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 opportunity in employment 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 consider qualified applicants regardless of criminal histories, consistent with legal requirements.
We’re 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 leavesandaccommodations@modernatx.com.
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