Submission Manager, Regulatory Operations

Moderna; Warszawa; On-site; PLN 140,000 - 230,000; Full time

Benefits offered by this job

Healthcare

Well-being resources

Family building benefits

Paid time off

Savings & investments

Location-specific perks

Job summary

Moderna Warsaw is seeking an experienced Regulatory Submissions Specialist to own planning, management and tracking of high-quality regulatory submissions across the global portfolio. You will partner with Regulatory Leads and cross-functional teams to orchestrate content from authoring through approval, publishing, QC and delivery to health authorities.

The role requires deep regulatory operations expertise, strong knowledge of eCTD/NeeS and lifecycle management, and the ability to lead

Qualifications

• Bachelor's degree in a scientific discipline or systems technology or equivalent.
• 5–8 years of pharmaceutical experience in a regulated life science environment.
• 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) and dossier preparation.
• Knowledge of CDISC (ADaM, SEND, SDTM).
• Demonstrated ability to lead and/or collaborate with cross-functional groups (Regulatory, clinical, nonclinical).
• Excellent document formatting/troubleshooting skills in MS Word/PDF Professional.
• MS PowerPoint skills and strong English proficiency.

Responsibilities

• Manage development and maintenance of detailed submission content plans from authoring through QC and delivery.
• Act as a global submissions expert with knowledge of eCTD, NeeS, and lifecycle management variations.
• Provide regulatory operations expertise to cross-functional submission teams as a primary contact.
• Plan and prepare high-quality global submissions with internal or CRO partners for health authorities.
• Oversee planning, publishing, validation and timely submission of INDs, NDAs, and MAAs.
• Manage publishing vendor activities to support high-quality submission packages and timely delivery.
• Communicate project status, issues, and milestones to management and stakeholders.
• Maintain regulatory requirements alignment with Moderna processes and client requirements.
• Serve as subject matter expert for Moderna’s document management system.
• Coordinate distribution of submissions to health authorities and CROs within agreed timelines.
• Manage submission and product lifecycle information throughout the regulatory process.
• Lead special projects across Regulatory, Clinical, Nonclinical and other functions.
• Apply MS Word/PDf formatting best practices and use PowerPoint for stakeholder communication.
• Engage with Generative AI tools to enhance regulatory operations while maintaining compliance.

Skills

Regulatory ops

eCTD publishing

NeeS standards

Lifecycle management

Cross-functional

Submission planning

Documentation formatting

English proficiency

Education

Bachelor's degree in science or systems tech

Tools

eCTD publishing systems

EDMS

Publishing tools

MS Word

MS PowerPoint

Job description

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.

This is an opportunity to take ownership of the planning, management and tracking of high-quality regulatory submissions across Moderna’s global portfolio. As an individual contributor and global submissions expert, you will partner closely with Regulatory Leads and cross-functional teams to orchestrate submission content from authoring through approval, publishing, quality control and delivery to health authorities.

You will bring deep regulatory operations expertise to major submissions, providing operational oversight across applications including INDs, NDAs and MAAs, as well as updates, amendments and variations. You will connect regulatory strategy with precise execution, ensuring teams understand eCTD, NeeS and lifecycle management requirements and the regional differences that shape global submission preparation.

Working in a highly digital regulatory environment, you will also have opportunities to get close to Generative AI tools and explore how emerging technologies can support regulatory operations, while maintaining the compliance, quality and technical rigor required for global submissions.

Here’s What You’ll Do:

• Manage the development and maintenance of detailed submission content plans, encompassing all source submission content—including documents and data—and track content through authoring, approval, publishing and QC.
• Serve as a global submissions expert, building project-team awareness and knowledge of electronic submission formats including eCTD and NeeS, lifecycle management concepts and relevant regional differences within global submission preparation.
• Provide regulatory operations expertise to cross-functional submission project teams and act as a primary point of contact for project and/or submission teams supporting major submissions.
• Partner with Regulatory Leads to plan and prepare high-quality global submissions, whether delivered in-house or through CRO partners, ensuring compliant submissions reach global health authorities within required timelines.
• Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications—including INDs, NDAs and MAAs—as well as updates, amendments and variations to regulatory agencies globally.
• Manage publishing vendor activities to support the preparation of high-quality submission packages and their timely delivery to health authorities.
• Effectively communicate project status, issues, schedules and accomplishments to management and stakeholder groups as required.
• Maintain technical expertise in regulatory requirements, ensuring alignment with Moderna processes and applicable client requirements.
• Act as a subject matter expert for Moderna’s document management system.
• Compile regulatory submissions and coordinate their distribution to all relevant parties, including health authorities and CROs, within agreed timelines.
• Manage submission and product lifecycle information throughout the regulatory process.
• Lead and manage special projects as required, bringing together stakeholders across Regulatory, Clinical, Nonclinical and other functions.
• Apply strong document formatting and troubleshooting capabilities across Microsoft Word and PDF Professional and use Microsoft PowerPoint to support effective stakeholder communication.
• Work within Moderna’s digital-first environment, gaining exposure to Generative AI tools and considering appropriate opportunities to enhance the efficiency and quality of regulatory operations while preserving regulatory compliance and human oversight.

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

• “We act with dynamic range, driving strategy and execution at the same time at every step.”
• “We digitize everywhere possible using the power of code to maximize our impact on patients.”

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
• Proficiency in English (verbal and/or written) required due to global collaboration needs.

Our Working Model

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.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive 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
• Savingsandinvestments 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, theinfrastructure 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 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.

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 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.

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].