Regulatory Submissions (Study Start-up) Coordinator - Experienced
On-site
Core
Prepare, review, and file clinical trial applications to domestic regulatory agencies; ensure compliance with regulations; advise sponsors on changing regulations.
Role type
Regulatory Submissions Coordinator (Study Start-up)
Builds
Clinical trial applications and regulatory responses for biotechnology, pharmaceutical, and medical device clients
Domain
Clinical Research / Regulatory Affairs
Required skills
Regulatory documentation preparation, compliance with European regulation (CTR), stakeholder advising, document tracking
Preferred skills
Knowledge of Microsoft Office
Technologies
Microsoft Office
Responsibilities
Prepare and submit responses to queries and amendments to clinical trial applications; Track submissions and ensure timely filing of documents
Seniority
Entry-level to Mid-level
