Country Approval Specialist - FSP - Portugal
Core
Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, special national applications) for clinical trials in alignment with global strategy.
Role type
Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and study files for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory submission coordination, local regulatory strategy advice, project coordination, stakeholder communication, documentation management, database maintenance, SOP compliance, feasibility coordination, budget negotiation support, patient information document development
Preferred skills
Knowledge of gene therapy approvals, viral safety dossiers, import licenses, start-up CRA collaboration, grant budget management
Technologies
PPD tracking databases, client SOPs, regulatory guidelines
Responsibilities
Prepare and coordinate local regulatory submissions under guidance; provide local regulatory strategy advice; coordinate project-specific SIA services; act as key contact for Ethical or Regulatory submissions; align site start-up activities with submission timelines; maintain trial status information in tracking databases; ensure study files and filing processes comply with SOPs.
Seniority
Mid-level, hands-on IC
