Experienced Regulatory Submissions Coordinator
Core
Coordinate regulatory submissions and ethics committee approvals to activate clinical trial sites in South Korea.
Role type
Regulatory Submissions Coordinator (Clinical Operations)
Builds
Activated investigative sites for clinical trials
Domain
Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory submission preparation, Ethics committee interaction, Risk identification, Document review, Compliance monitoring, Query response formulation
Preferred skills
CRO or Pharmaceutical industry experience, ICH-GCP knowledge, Microsoft Office proficiency
Technologies
Microsoft Office
Responsibilities
Prepare, review, and submit regulatory applications to MFDS 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 ethical and regulatory submissions; Direct contact with investigative sites during startup; Ensure compliance with regulations; Advise sponsors on regulatory changes; Track submissions for timely filing.
