Regional Clinical Trial Submission Manager – Shanghai or Seoul
Pfizer
full-time
Posted on:
Location Type: Office
Location: Shanghai • 🇨🇳 China
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Accountable for the timely and compliance delivery of Clinical Trial Applications
- Drive submission management activities for assigned protocols
- Support and lead regional and global efforts to ensure quality components and submissions
- Liaise with GSSO regarding essential documents for submission
- Responsible for the co-ordination of translations required for submission
- Acts as Subject Matter Expert for CTRSE and provides country-level intelligence on regulatory processes
Requirements
- A degree in Pharmacy, Life Sciences, Business or Information Technology
- Minimum 6 years’ experience in clinical trials or equivalent relevant professional experience
- Comprehensive understanding of ICH/GCP guidelines
- Familiarity with pharmaceutical organizational structures, systems, and culture preferred
- Fluent in both written and spoken English.
Benefits
- Professional development
- Flexible working hours
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Trial Applicationssubmission managementregulatory processestranslations coordinationICH guidelinesGCP guidelines
Soft skills
leadershipcommunicationorganizational skillscollaboration