Global Regulatory CTA Operations Leader

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

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.