Regulatory and Start Up Specialist
Core
Regulatory and Start Up Specialist responsible for site activation readiness, clinical trial application submissions, and contract/budget negotiations in Spain.
Role type
Senior IC Regulatory and Start Up Specialist
Builds
Site activation and clinical trial authorizations
Domain
Clinical Research / Oncology / Rare Diseases
Required skills
Regulatory submissions, contract negotiation, budget negotiation, site activation management, CA/EC interaction, document translation coordination, local clinical trial law knowledge
Preferred skills
Pharmacy qualification, 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 investigator contracts and study budgets; maintain audit/inspection readiness; customize Patient Information Sheets and Informed Consent Forms; coordinate document translations; support feasibility and site outreach.
Seniority
Senior, hands-on IC
