Regional Clinical Trial Submission Manager

Pfizer

Hybrid
Clinical trial application submissions
Health authority and ethics committee liaison
Regulatory intelligence for apac countries
Accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics

Job Summary

  • Accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics.
  • Focuses on CTA submissions in Korea and other APAC countries, providing project leadership and expertise.
  • Serves as Pfizer CTRSE representative with Health Authority meetings and contributes to changes in policies and strategies.

Matching Summary

Accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics.

Skills & Requirements

Must-have

  • Clinical Trial Application submissions
  • Health Authority and Ethics Committee liaison
  • Regulatory intelligence for APAC countries
  • Project management for clinical trials
  • Submission component authoring and delivery

Nice-to-have

  • Mentoring and motivating colleagues
  • Driving innovative ideas
  • Embracing new technologies

Key Requirements

  • Minimum 6 years experience in clinical trials
  • Comprehensive understanding of ICH/GCP guidelines
  • CTA regulations and process in China and other APAC countries
  • Proven technical aptitude and ability to learn new software

Work Rights

Not specified

Tailored Resume

Cover Letter