The CTRSE Regional Submission Manager is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics
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 China and other APAC countries, providing project leadership and expertise in regulatory Clinical Trial Application submissions.
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
The CTRSE Regional Submission Manager is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics.
Skills & Requirements
Must-have
Clinical Trial Applications
Health Authority submissions
Central Ethics Committee submissions
APAC regulatory intelligence
Regulatory submission execution
Nice-to-have
Project management expertise
Cross-functional collaboration
Mentoring and motivating colleagues
Innovative problem-solving
Key Requirements
Minimum 6 years experience in clinical trials
Degree in Pharmacy, Life Sciences, Business or IT
Comprehensive understanding of ICH/GCP
CTA regulations and process in China and APAC countries