Global CTA & Regulatory Operations Manager

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

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.