Submission Manager, Regulatory Operations

Moderna Therapeutics; Warszawa; Hybrid; PLN 180,000 - 320,000; Full time

Benefits offered by this job

Competitive healthcare

AI-assisted tools exploration

In-office collaboration (70/30)

Job summary

Moderna Therapeutics seeks a Submission Manager in Warsaw to own planning, management and tracking of regulatory submissions across a global portfolio. You will work with Regulatory Leads and cross-functional teams to author, publish, QA and deliver content to health authorities.

You will ensure expertise in eCTD, NeeS, lifecycle management, and regional differences while exploring Generative AI tools to enhance regulatory operations with high quality and compliance.

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 knowledge of eCTD publishing systems and EDMS.
• North American/Global submission standards (FDA, Health Canada, EMA, ICH) knowledge.
• Ability to lead cross-functional groups (Regulatory, clinical, nonclinical).
• Strong MS Word/PDF formatting and troubleshooting skills.
• Proficiency in English for global collaboration.

Responsibilities

• Develop and maintain submission content plans covering all source documents and data.
• Serve as global submissions expert on eCTD and NeeS formats and lifecycle management.
• Provide regulatory operations expertise to cross-functional submission teams.
• Plan and prepare high-quality global submissions with in-house or CRO partners.
• Oversee publishing and timely submission of INDs, NDAs and MAAs to health authorities.
• Manage publishing vendor activities for submission packages.
• Communicate project status, issues and milestones to management and stakeholders.
• Maintain alignment with regulatory requirements and Moderna document management standards.
• Coordinate distribution of submissions to health authorities and CROs.

Skills

eCTD publishing

EDMS technology

Regulatory submissions

Cross-functional collaboration

MS Word formatting

MS PowerPoint

English proficiency

Education

Bachelor's degree in science or systems technology

Tools

MS Word

PDF Professional

PowerPoint

Job description

## Submission Manager, Regulatory OperationsApply: Warsaw - Poland: Clinical Development: Full time: Posted Today: R19834If you’re interested in this role, please apply in English and include an English version of your Resume/CV.**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. 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* 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.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 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].