Manager, Global Regulatory Science CTA

Moderna Therapeutics; Województwo mazowieckie; On-site; PLN 200,000 - 320,000; Full time

Benefits offered by this job

Competitive healthcare

Family building benefits

Generous paid time off

In-office collaboration model

Job summary

Moderna Therapeutics in Warsaw is seeking an experienced Regulatory CTA professional to lead end-to-end CTA operations outside the United States, coordinating cross-functional teams and CROs while ensuring compliance with EU regulatory requirements.

You will manage CTIS/IRAS/Veeva RIM records, support DSUR submissions, and contribute to the creation of Development Medicinal Products in the xEVMPD system to enable global submissions for our growing mRNA portfolio.

Qualifications

• Bachelor’s degree in life science or related discipline.
• 5+ years of experience in the pharmaceutical industry.
• 4+ years of Regulatory CTA experience.
• Experience in EU regulatory submissions for clinical trials.
• Proficiency in English required.

Responsibilities

• Lead end-to-end global CTA operations outside the US.
• Coordinate cross-functional activities and submission tracking across regions.
• Partner with Global Regulatory Leads (GRLs) to align strategies and timelines.
• Oversee CROs to ensure timely CTA delivery and clear progress.
• Manage CTA packages, timelines and regulatory records (CTIS/IRAS/Veeva RIM).
• Support DSUR submission oversight and xEVMPD data entry.

Skills

Team collaboration

English proficiency

Regulatory CTA experience

EU regulatory knowledge

Education

Bachelor's degree in life science

Tools

CTIS

IRAS

Veeva RIM

Job description

If 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.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 discipline5+ years of experience in the pharmaceutical industry.4+ years of experience in Regulatory CTAExperience in the preparation/submission of regulatory documentation to support clinical trials applications/amendments in the European UnionGood understanding of the Regulation (EU) 536/2014 and Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025Proven 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 CollaborativeProficiency in English (verbal and/or written) required due to global collaboration needsOur Working ModelAs 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 & BenefitsAt 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 needsA holistic approach to well-being with access to fitness, mindfulness, and mental health supportFamily building benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince 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] .-