Regional Clinical Trial Submission Manager

Data Science Jobs

Seoul, South Korea
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Clinical trial application submissions
Regulatory compliance management
Project leadership in clinical trials
** The Regional Clinical Trial Submission Manager position at Data Science Jobs in Seoul, South Korea, involves overseeing the timely and compliant delivery of Clinical Trial Applications (CTAs) across multiple therapeutic areas and markets. The role requires strong project management skills and expertise in regulatory submissions, focusing on the APAC region. **

Job Summary

  • The Regional Clinical Trial Submission Manager is accountable for the timely and compliant delivery of Clinical Trial Applications to Health Authorities and Central Ethics across multiple therapeutic areas and markets.
  • This role provides project leadership and expertise in the strategic and operational execution of regulatory Clinical Trial Application submissions in Korea and other APAC countries.
  • The position involves acting as a Subject Matter Expert, driving communication with stakeholders, and contributing to policy and strategy changes to meet evolving business needs.

Matching Summary

Match Score: 75

** The Regional Clinical Trial Submission Manager position at Data Science Jobs in Seoul, South Korea, involves overseeing the timely and compliant delivery of Clinical Trial Applications (CTAs) across multiple therapeutic areas and markets. The role requires strong project management skills and expertise in regulatory submissions, focusing on the APAC region. **

Skills & Requirements

Must-have

  • Clinical Trial Application submissions
  • Regulatory compliance management
  • Project leadership in clinical trials
  • Knowledge of ICH/GCP guidelines
  • Coordination of translation for submissions
  • Interface with health authorities and ethics committees

Nice-to-have

  • Mentoring and motivating colleagues
  • Collaboration with global and regional partners
  • Driving process improvement projects
  • Experience with pharmaceutical organizational culture
  • Fluent written and spoken English

Key Requirements

  • Minimum 6 years clinical trials experience
  • Degree in Pharmacy, Life Sciences, Business or IT
  • Comprehensive understanding of ICH/GCP guidelines
  • In-depth knowledge of CTA regulations in China and APAC
  • Proven ability to lead in a matrix model
  • Fluency in English

Work Rights

Not specified

Tailored Resume

Cover Letter