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 a Subject Matter Expert, driving submission teams towards the delivery of globally compliant components while managing translation and compilation processes.
The position requires leading project management activities for clinical trials, liaising with GSSO partners, and representing Pfizer in meetings with Health Authorities.
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.
Skills & Requirements
Must-have
Clinical Trial Application submission management
ICH/GCP guidelines and CTA regulations
APAC regional regulatory filing experience
Matrix model leadership and delivery
Regulatory intelligence and country-level knowledge
Nice-to-have
Mentoring and motivating colleagues
Embracing new technologies and processes
Innovative problem-solving in ambiguous situations
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 ICH/GCP and CTA regulations