The role is accountable for the timely and compliant delivery of Clinical Trial Applications to Health Authorities and Central Ethics across multiple markets in the APAC region
Job Summary
The role is accountable for the timely and compliant delivery of Clinical Trial Applications to Health Authorities and Central Ethics across multiple markets in the APAC region.
Candidates will serve as Subject Matter Experts, leading submission teams to deliver globally compliant components while managing translation processes and essential documents.
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 multiple markets in the APAC region.
Salary
Not specified; Not specified; Not specified
Skills & Requirements
Must-have
Clinical Trial Application submission management
ICH/GCP guidelines compliance
APAC regional regulatory filing experience
Health Authority liaison capabilities
Cross-functional team leadership
Nice-to-have
Mentoring and professional development skills
Innovative problem-solving abilities
Familiarity with pharmaceutical organizational culture
Experience with global submission strategies
Key Requirements
Minimum 6 years' experience in clinical trials
Degree in Pharmacy, Life Sciences, Business, or IT
Comprehensive understanding of ICH/GCP and CTA regulations