Pfizer is seeking a Regional Clinical Trial Submission Manager in Seoul, South Korea, responsible for managing the timely and compliant submission of Clinical Trial Applications (CTAs) across multiple therapeutic areas and markets. The ideal candidate should have significant experience in clinical trials, regulatory sciences, and a strong understanding of regional regulatory guidelines
Job Summary
The CTRSE Regional Submission Manager is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics.
This role will focus on the CTA submissions in Korea and other APAC countries, providing project leadership and expertise.
The CT-SM is required to author & deliver customized documentation for selected submissions across multiple markets and may be assigned as a Global Submission Manager.
Matching Summary
Match Score: 85
Pfizer is seeking a Regional Clinical Trial Submission Manager in Seoul, South Korea, responsible for managing the timely and compliant submission of Clinical Trial Applications (CTAs) across multiple therapeutic areas and markets. The ideal candidate should have significant experience in clinical trials, regulatory sciences, and a strong understanding of regional regulatory guidelines.
Skills & Requirements
Must-have
Clinical Trial Application submissions
Health Authority and Ethics Committee submissions
Regional submission management
Regulatory intelligence
Project management for clinical trials
Nice-to-have
Mentoring and motivating colleagues
Driving process improvement projects
Developing innovative ideas
Familiarity with pharmaceutical organizational structures
Key Requirements
Minimum 6 years experience in clinical trials
Degree in Pharmacy, Life Sciences, Business or IT
Comprehensive understanding of ICH/GCP guidelines
Understanding of CTA regulations and process in China and other APAC countries