Regulatory and Start Up Specialist
Core
Regulatory and Start Up Specialist ensuring site activation readiness, preparing clinical trial applications, and managing site contracts/budgets for Germany, Austria, and Switzerland.
Role type
Senior IC regulatory and start-up specialist
Builds
Site activation readiness and clinical trial authorizations
Domain
Clinical Research Organization (CRO) / Precision Medicine / Oncology & Rare Diseases
Required skills
Regulatory submissions (CTA), site contract negotiation, budget negotiation, Competent Authority interaction, Ethics Committee management, project planning, document translation coordination, local clinical trial law knowledge
Preferred skills
Pharmacy qualification, advanced degree (MD/PhD/PharmD), RAC certification, Masters in Regulatory Science, milestone tracking tools experience
Technologies
Electronic spreadsheets, word processing, electronic mail, computerized information systems, milestone tracking tools
Responsibilities
Prepare Clinical Trial Application Forms and submission dossiers; interact with Competent Authorities and Ethics Committees; negotiate site contracts and study budgets; maintain audit/inspection readiness; customize Patient Information Sheets and Informed Consent Forms; coordinate document translations; support feasibility assessments and pre-study site visits.
Seniority
Mid-Senior, hands-on IC
