Global CTA Operations Lead – Regulatory Science

Moderna; Województwo mazowieckie; On-site; PLN 320,000 - 520,000; Full time

Benefits offered by this job

Healthcare

Well-being resources

Family benefits

Generous paid time off

Investments and savings plans

Location-specific perks

Job summary

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.

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 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.

Skills

Bachelor’s degree in life science

5+ years pharmaceutical industry

4+ years Regulatory CTA

EU regulatory submissions

English proficiency

Cross-functional collaboration

Education

Bachelor’s degree in life science

Tools

CTIS

IRAS

Veeva RIM

Job description

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