Regulatory Submissions-Start Up & Contract Specialist (dual role)
Core
Prepare, review, and file clinical trial applications to regulatory authorities and Ethics committees; draft, negotiate, and finalize legal agreements for clinical studies.
Role type
Regulatory Submissions Coordinator & Contract Specialist
Builds
Clinical trial submissions and legal agreements for drug release
Domain
Clinical research / Regulatory affairs / Contract management
Required skills
Regulatory documentation preparation, contract negotiation, risk assessment, Clinical Trial Management System (CTMS) maintenance, local regulatory knowledge, document collection
Preferred skills
Life Sciences or Law degree, CRO/Pharma experience, independent work, Microsoft Office
Technologies
Clinical Trial Management System, Microsoft Office
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