Senior Country Approval Specialist
Core
Manage preparation, review, and coordination of local regulatory submissions for clinical trials in alignment with global strategy.
Role type
Senior Country Approval Specialist (Regulatory Submissions)
Builds
Regulatory submission packages and country-specific study documentation
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission coordination, regional regulatory strategy, stakeholder management with authorities, compliance review, study file oversight, contract scope identification, feasibility coordination, database maintenance, SOP adherence, team mentoring
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, grant budget support
Technologies
Regulatory databases, submission management software
Responsibilities
Prepare and coordinate local regulatory submissions (MoH, EC, gene therapy, viral safety dossiers), provide regional regulatory strategy advice, serve as primary contact for investigators and local authorities, develop country-specific Patient Information Sheets and Informed Consent forms, oversee country study files, mentor team members, resolve regulatory process anomalies
Seniority
Senior, hands-on IC
