The role is accountable for the timely and compliant delivery of Clinical Trial Applications to Health Authorities and Central Ethics across Korea and other APAC countries
Job Summary
The role is accountable for the timely and compliant delivery of Clinical Trial Applications to Health Authorities and Central Ethics across Korea and other APAC countries.
Candidates must act as a Subject Matter Expert to lead submission teams, author customized documentation, and ensure globally compliant submission-ready components.
This position requires driving communication with stakeholders, representing Pfizer at Health Authority meetings, and contributing to policy changes to meet evolving business needs.
Matching Summary
The role is accountable for the timely and compliant delivery of Clinical Trial Applications to Health Authorities and Central Ethics across Korea and other APAC countries.
Skills & Requirements
Must-have
Clinical Trial Application submission management
APAC regional regulatory compliance expertise
Health Authority and Central Ethics liaison
ICH/GCP guidelines knowledge
CTA dossier preparation and review
Nice-to-have
Mentoring and motivating colleagues
Innovative problem solving skills
Fluent in written and spoken English
Experience with matrix model leadership
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 CTA regulations in China and APAC
Proven technical aptitude for new software and regulations