Regulatory and Start Up Specialist (Portuguese speaker)
Core
Regulatory and Start Up Specialist ensuring site activation readiness, preparing clinical trial applications, and managing local regulatory submissions for clinical trials.
Role type
Regulatory and Start Up Specialist
Builds
Clinical trial authorizations and site activations
Domain
Clinical Research / Precision Medicine
Required skills
Regulatory submissions, site activation readiness, contract negotiation, budgeting negotiation, translation coordination, local law knowledge, stakeholder communication
Preferred skills
Pharmacy qualification, advanced degree in medical/life sciences, RAC certification, Masters in Regulatory Science
Technologies
Computerized information systems, electronic spreadsheets, word processing, milestone tracking tools
Responsibilities
Prepare Clinical Trial Application Forms and submission dossiers; interact with Competent Authorities/Ethics Committees; maintain project plans and regulatory intelligence tools; support study budget and investigator contract negotiations; customize Patient Information Sheets and Informed Consent Forms; coordinate document translations; maintain audit/inspection readiness; support Pre-Study Site Visits.
Seniority
Mid-level Specialist
