Manager, Global Regulatory Science CTA

Moderna; Warszawa; On-site; PLN 240,000 - 360,000; Full time

Job summary

Moderna, based in Warsaw, is seeking an experienced regulatory professional to lead end-to-end global Clinical Trial Applications outside the United States. You will coordinate cross-functional teams, CROs, and Health Authority submissions to ensure timely and compliant CTA delivery across regions.

You will align strategies with Global Regulatory Leads and oversee regulatory databases (CTIS, IRAS, Veeva RIM), manage queries, and maintain dossiers.

Qualifications

• At least a bachelor's degree in life science or related discipline.
• 5+ years in the pharmaceutical industry.
• 4+ years of experience in Regulatory CTA.
• Experience in EU regulatory submissions for clinical trials.
• Knowledge of EU 536/2014 and related regulations.

Responsibilities

• Lead end-to-end global CTA operations outside the US with cross-functional coordination.
• Partner with Global Regulatory Leads to align CTA strategies and plans.
• Oversee CROs to ensure timely CTA delivery and progress visibility.
• Prepare, review, and execute CTA submission packages for Health Authorities.
• Manage CTIS, IRAS, and Veeva RIM records and submissions.
• Coordinate regulatory query management and responses across teams.
• Maintain quality regulatory documentation and dossier management.
• Support DSUR submission oversight and regulatory information systems updates.
• Contribute to cross-functional development of Development Medicinal Products in xEVMPD.

Skills

Regulatory coordination

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in life sciences

Tools

CTIS

IRAS

Veeva RIM

Job description

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