Country Approval Specialist - FSP
Core
Manage and coordinate local regulatory submissions for clinical trials across multiple countries to ensure alignment with global strategy and timely site activation.
Role type
Senior IC clinical operations specialist (country approval)
Builds
Clinical trial submissions and site startup processes for pharmaceutical and biotech clients
Domain
Clinical research / pharmaceutical regulatory affairs
Deliverable
client delivery
Required skills
Regulatory submission preparation and review, site document collection and validation, cross-functional partnership with CROs and internal teams, timeline tracking and escalation, eTMF management, clinical trial agreement and budgeting knowledge, FDA and ICH-GCP guidelines knowledge, regional/national regulatory guideline knowledge
Preferred skills
Gene therapy or viral safety dossier experience, medical/therapeutic area knowledge
Technologies
eTMF systems, clinical trial management software
Responsibilities
Prepare and review local regulatory submissions (MoH, EC, special national applications), collect and review site essential documents (ICF, FDF, 1572, CVs), partner with Study Startup and CROs to improve metrics, track site activation timelines, resolve escalated issues, provide feedback on site performance metrics, ensure eTMF accuracy during startup
Seniority
Mid-level, hands-on IC
