Regional Clinical Trial Submission Manager

Pfizer Com Sg

Singapore
Hybrid
Clinical trial applications
Health authorities and central ethics
Regulatory clinical trial application (cta) submissions
The CTRSE Regional Submission Manager is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics, leading project management activities for Clinical Trials across multiple TAs, Phases and Markets

Job Summary

  • The CTRSE Regional Submission Manager is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics, leading project management activities for Clinical Trials across multiple TAs, Phases and Markets.
  • This role will focus on the CTA submissions in China and other APAC countries, acting as a Subject Matter Expert for CTRSE and providing country-level intelligence on clinical trial regulatory matters.
  • The CT-SM is required to author & deliver customized documentation for selected submissions across multiple markets and may be assigned as a Global Submission Manager to meet business demands.

Matching Summary

The CTRSE Regional Submission Manager is accountable for the timely and compliance delivery of Clinical Trial Applications to both Health Authorities and Central Ethics, leading project management activities for Clinical Trials across multiple TAs, Phases and Markets.

Skills & Requirements

Must-have

  • Clinical Trial Applications
  • Health Authorities and Central Ethics
  • regulatory Clinical Trial Application (CTA) submissions
  • submission execution timelines
  • ICH/GCP guidelines
  • CTA regulations and process in China and other APAC countries

Nice-to-have

  • project leadership and expertise
  • strategic and operational execution
  • Subject Matter Expert
  • collaboration with stakeholders
  • innovative ideas to resolve complex problems

Key Requirements

  • Minimum 6 years’ experience in clinical trials
  • Degree in Pharmacy, Life Sciences, Business or Information Technology
  • Comprehensive understanding of ICH/GCP guidelines
  • In-depth understanding and proven execution of CTA processes globally
  • Fluent in both written and spoken English

Work Rights

Not specified

Tailored Resume

Cover Letter