Regulatory Submissions Coordinator
Core
Coordinate regulatory submissions and site activation activities for clinical trials to support drug development.
Role type
Regulatory Submissions Coordinator
Builds
Regulatory submissions and site activation documentation for clinical trials
Domain
Clinical Research / Biopharmaceuticals
Required skills
Regulatory submission preparation, Site activation coordination, Ethics committee communication, Risk mitigation, ICH-GCP guidelines knowledge, Document review and finalization
Preferred skills
CRO or Pharmaceutical industry experience, Investigative site experience, Regulatory guideline knowledge
Technologies
Microsoft Office
Responsibilities
Prepare, review, and submit regulatory applications to agencies and ethics committees; Coordinate site activation activities across clinical trial phases; Communicate with global study teams and investigative sites; Identify and mitigate risks to site activation; Ensure compliance with applicable regulations and guidance documents; Track submissions to ensure timely filing.
Seniority
Mid-level, hands-on IC
