Sr. Specialist, Regulatory Operations

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.

The Senior Submissions Specialist, Regulatory Operations is a vital part of our global Regulatory Operations team. In this role, you will coordinate and track regulatory submissions, partnering with the Regulatory Lead to prepare high-quality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to cross-functional submission teams, driving excellence in planning, preparation, and compliance, while serving as the key point of contact for project and submission activities.

Here's What You'll Do
Your key responsibilities will be:

• Coordinating the development and maintenance of a submission content plan with guidance from senior Regulatory Operations personnel.
• Ensuring project teams understand and align with global e-submissions standards (eCTD, NeeS) and life cycle management concepts, while navigating regional differences effectively.
• Providing operational support for the planning, preparation, publishing, validation, and submission of applications such as BLAs, MAAs, and Variations, and ensuring their timely delivery to global health authorities.
• Leading and coordinating activities with publishing vendors to produce high-quality submission packages.
• Collaborating on special projects and driving operational excellence in all submission-related processes.

Your Responsibilities Will Also Include

• Maintaining technical expertise of regulatory requirements to ensure compliance with company and client standards.
• Managing distribution of submissions to health authorities, CROs, and other stakeholders within agreed timeframes.
• Effectively communicating project status, schedules, and deliverables to management and stakeholders.

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

• We act with urgency: In regulatory submissions, timely and accurate delivery saves lives. You'll thrive in fast-paced environments where responsiveness is crucial.
• We behave like owners: Taking full accountability for your projects, you'll own the success of submission strategies, embodying a solutions-oriented mindset.

Here's What You'll Bring To The Table

• Bachelor's degree in a scientific discipline or systems technology or equivalent
• 3-5 years of pharmaceutical experience working in a regulated, life science
• environment (pharmaceutical, biotechnology, consumer health)
• Working knowledge of eCTD publishing systems, EDMS technology, and
• related publishing tools (Veeva RIM).
• Working knowledge of European, EEA, Western Europe, US, and ROW electronic submission standards and industry trends for electronic submission requirements.
• Knowledge of SPOR, and IDMP requirements.
• A demonstrated ability to collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)
• Strong attention to detail and ability to work in a fast-paced environment
• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional
• Excellent English Language Skills.

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.

• 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, global recharge days, and a discretionary year-end shutdown
• 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 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