Manager, Global Regulatory Science CTA

Moderna; Województwo mazowieckie; Sur place; PLN 320 000 - 520 000; Plein temps

Avantages offerts par ce poste

Healthcare

Well-being resources

Family benefits

Generous paid time off

Investments and savings plans

Location-specific perks

Résumé du poste

Moderna is strengthening its international business services hub in Warsaw, leading worldwide Clinical Trial Application (CTA) operations outside the United States. Based in Warsaw as an individual contributor, you will coordinate regulatory submissions and CRO activities, ensuring compliance with country-specific CTA requirements.

You’ll work with cross-functional teams and Global Regulatory Leads, supporting DSUR oversight and xEVMPD data creation, while maintaining regulatory records across

Qualifications

• Bachelor’s degree in life science or related field.
• 5+ years in the pharmaceutical industry.
• 4+ years in Regulatory CTA activities.
• Experience preparing/submitting regulatory docs for EU clinical trials.
• Strong understanding of EU 536/2014 regulations.
• Ability to work in cross-functional teams and build relationships.
• English proficiency for global collaboration.

Responsabilités

• Lead end-to-end global CTA operations outside the US with cross-functional coordination.
• Partner with Global Regulatory Leads to align CTA strategies and timelines.
• Oversee CROs to ensure timely CTA delivery and progress tracking.
• Prepare, review, and execute CTA submission packages per country requirements.
• Manage regulatory databases and sponsor-side administration (CTIS, IRAS, Veeva RIM).
• Coordinate regulatory queries and timely responses with program teams.
• Maintain high-quality regulatory documentation and dossiers.
• Support DSUR submission oversight and xEVMPD regulatory data creation.

Connaissances

Bachelor’s degree in life science

5+ years pharmaceutical industry

4+ years Regulatory CTA

EU regulatory submissions

English proficiency

Cross-functional collaboration

Formation

Bachelor’s degree in life science

Outils

CTIS

IRAS

Veeva RIM

Description du poste

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.

Based in Warsaw as an individual contributor, you will lead worldwide Clinical Trial Application (CTA) operations outside the United States, excluding US Investigational New Drug (IND) submissions.

You will provide operational and regulatory support across global programs, connecting cross-functional teams, contract research organizations (CROs), and Health Authority submission activities while ensuring compliance with country-specific CTA requirements.

Your remit will also include Development Safety Update Report (DSUR) submission oversight and supporting the creation of Development Medicinal Products in the xEVMPD system.

Here’s What You’ll Do

• Lead end-to-end global CTA operations outside the US, coordinating cross-functional activities and submission tracking across regions. Bring together operational planning, regulatory requirements, and execution to support timely, compliant submissions to Health Authorities.
• Partner with Global Regulatory Leads (GRLs) to ensure program strategies are aligned across regions and reflected in CTA submission plans, timelines, and operational priorities.
• Oversee and coordinate CROs to support timely CTA delivery, aligning submission activities and deliverables with program needs and maintaining clear visibility of progress across global regions.
• Oversee the preparation, review, and execution of CTA submission packages, managing associated timelines and operational plans. Coordinate cross-functional inputs and delivery to Health Authorities, ensuring packages meet country-specific CTA requirements.
• Manage regulatory databases and sponsor-side administration within CTIS, IRAS, and Veeva RIM, ensuring accurate tracking, effective submission management, and complete regulatory records throughout CTA execution.
• Oversee regulatory query management, coordinating cross-functional and CRO contributions to Health Authority responses and driving timely resolution while maintaining alignment with the relevant program strategy.
• Maintain high-quality regulatory documentation and dossier management practices, supporting compliance, record completeness, and audit readiness across global CTA activities.
• Support the cross-functional team with DSUR submission oversight, coordinating relevant operational inputs and monitoring submission progress to support timely delivery.
• Support the creation of Development Medicinal Products in the xEVMPD system, working with cross-functional colleagues to ensure the associated regulatory information is accurately captured.

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.” You will connect program-level regulatory strategy with detailed operational execution, moving between global stakeholder coordination, CRO oversight, submission planning, and regulatory query resolution. Success means maintaining a clear view of program objectives while ensuring the accuracy and completeness of each submission and regulatory record.
• “We digitize everywhere possible using the power of code to maximize our impact on patients.” You will apply a digital mindset to regulatory systems, information quality, and submission management. This includes exploring opportunities to work with generative AI tools to support regulatory information retrieval, document workflows, and operational tracking, with appropriate human review, confidentiality safeguards, and attention to applicable regulatory requirements.

Here’s What You’ll Need (Basic Qualifications)

• At least bachelor’s degree in life science or related discipline
• 5+ years of experience in the pharmaceutical industry.
• 4+ years of experience in Regulatory CTA
• Experience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European Union
• Good understanding of the Regulation (EU) 536/2014 and Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
• Proven ability to work within multi-functional teams, building strong and productive relationships across an organization.
• A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
• 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.

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].