Senior Submission Manager

Moderna; Województwo mazowieckie; On-site; PLN 298,000 - 384,000; Full time

Job summary

A leading biotechnology firm in Warsaw is seeking a Senior Manager for Regulatory Operations. The successful candidate will oversee global regulatory submissions, ensuring compliance and collaboration with cross-functional teams. Applicants should have 5-8 years of pharmaceutical experience and advanced knowledge in regulatory standards. A degree in a scientific discipline is required. This role offers an opportunity to impact global health initiatives and work in a dynamic environment.

Benefits

Quality healthcare and insurance benefits

Generous paid time off

Lifestyle Spending Accounts

Free fitness classes

Qualifications

• 5-8 years of pharmaceutical experience in a regulated environment.
• Advanced working knowledge of eCTD publishing systems.
• Excellent document formatting/troubleshooting skills.

Responsibilities

• Lead global regulatory submissions from planning to submission.
• Ensure compliance with regional and global submission standards.
• Collaborate with vendors for timely submission packages.

Skills

Pharmaceutical experience

eCTD publishing systems knowledge

Collaboration with cross-functional teams

Document formatting skills

Education

Bachelor’s degree in a scientific discipline

Tools

MS Word

PDF Professional

MS PowerPoint

Job description

Overview

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 Senior Manager, Regulatory Operations, you will be the driving force behind the preparation and execution of high-quality global submissions across a diverse portfolio. Reporting into Regulatory Affairs, and partnering closely with the Regulatory Lead, you will serve as a primary point of contact for cross-functional submission project teams and provide deep technical guidance on planning, publishing, and delivering regulatory submissions. Your role will be instrumental in setting global standards, managing systems and tools, and ensuring compliance with health authority requirements worldwide. This is a Warsaw-based individual contributor position with a global remit, providing the opportunity to influence global regulatory operations while remaining deeply hands-on. With close exposure to systems implementation, metrics collection, and lifecycle submission strategy, this role sits at the nexus of compliance, innovation, and operational excellence. You will also work on integrating GenAI tools into submission workflows, pushing the boundaries of how technology enables Regulatory Operations at Moderna.

Here’s What You’ll Do:

Your key responsibilities will be:

• Act as operational lead for global regulatory submissions (IND, NDA, MAA, amendments, variations), from planning through submission.
• Collaborate with Regulatory Leads to develop and maintain comprehensive global content plans, ensuring traceability from source documentation through QC and approval.
• Serve as the point of contact for submission-related matters across internal teams and external vendors.
• Ensure all eCTD and NeeS submission components meet regional and global standards, including lifecycle management.
• Administer and act as SME for Moderna’s document management systems, leading document tracking, archiving, and compliance protocols.

Your responsibilities will also include:

• Vendor oversight: manage CROs and publishing vendors to ensure timely and accurate submission packages.
• Lead or support special projects aimed at improving Regulatory Operations capabilities, including GenAI initiatives and digitization efforts.
• Support definition and implementation of global submission standards, SOPs, and work instructions.
• Monitor evolving regulatory and technical requirements, ensuring Moderna stays aligned with industry and authority expectations.
• Coordinate internal dissemination of lessons learned and best practices across submission teams.

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

• “We digitize everywhere possible using the power of code to maximize our impact on patients.” This mindset will be essential as you work to implement systems, lead digitization efforts in document and submission workflows, and engage with GenAI tools to elevate regulatory operations.

• “We behave like owners. The solutions we’re building go beyond any job description.” You will act as the go-to expert and project lead in Warsaw for global submissions, proactively driving improvements and ensuring best-in-class operational delivery at every stage of the regulatory lifecycle.

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

• Bachelor’s degree in a scientific discipline or systems technology or equivalent
• 5-8 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)
• Advanced working knowledge of eCTD publishing systems, EDMS technology, and related publishing tools
• Extensive knowledge of North American/Global submission standards (FDA, Health Canada, EMA, ICH, eCTD, etc.) and industry trends for dossier preparation (INDs, CTAs, etc.)
• Knowledge of CDISC (ADaM, SEND, SDTM)
• A demonstrated ability to lead and/or collaborate with groups cross-functionally (Regulatory, clinical, nonclinical, etc.)
• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional
• MS PowerPoint skills

Benefits

• 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 the Moderna careers page 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 [e-mail].