Regulatory Submissions Coordinator
Core
Prepare, review, and file clinical trial applications for Germany, Austria, and Switzerland; communicate with research sites to collect essential documents for patient enrollment.
Role type
Regulatory Submissions Coordinator
Builds
Clinical trial submissions for biotechnology, pharmaceutical, and medical device industries
Domain
Clinical research / Regulatory affairs
Required skills
Clinical trial management, regulatory compliance, document preparation, timeline management, stakeholder communication, attention to detail
Preferred skills
Life Sciences background, knowledge of DACH regulations
Technologies
Microsoft Office
Responsibilities
Prepare, review, and file clinical trial applications; Communicate with research sites to collect essential documents; Provide input on regulatory submissions documents; Ensure submissions comply with applicable regulations; Advise on changing country regulations; Track submissions and ensure timely filing.
Seniority
Entry-level