Experienced Regulatory Submissions Coordinator
Core
Coordinate regulatory submissions and ethics committee approvals to activate clinical trial sites in Taiwan.
Role type
Regulatory Submissions Coordinator (Clinical Operations)
Builds
Activated investigative sites for clinical trials
Domain
Clinical Research / Regulatory Affairs
Deliverable
physical/clinical work
Required skills
Regulatory submission preparation, Ethics committee communication, Risk identification, Document review, Compliance knowledge, Query response formulation
Preferred skills
CRO or Pharmaceutical industry experience, ICH-GCP guidelines knowledge, Microsoft Office proficiency
Technologies
Microsoft Office
Responsibilities
Prepare, review, and submit regulatory applications to agencies and ethics committees; Communicate with global study teams on progress; Identify and mitigate risks to site activations; Finalize essential documents for site activation; Act as main contact for submission activities; Direct contact with investigative sites during startup; Ensure compliance with regulations; Advise sponsors on regulatory changes; Track submissions for timely filing.
