Senior Country Approval Specialist---Startup Lead
Core
Manages the preparation, review, and coordination of country submissions for clinical trials in alignment with global strategy.
Role type
Senior regulatory submission specialist (clinical trials)
Builds
Regulatory compliance review packages and country-specific submission strategies
Domain
Clinical research / Life sciences / Regulatory affairs
Required skills
Regulatory guidelines knowledge, submission coordination, strategy development, stakeholder management, documentation quality, negotiation, medical terminology, database management, SOP adherence
Preferred skills
Mentorship, issue resolution, contract analysis, feasibility coordination
Technologies
Clinical trial databases, regulatory software
Responsibilities
Prepare and coordinate country submissions (MoH, EC, safety dossiers), develop local submission strategies, serve as primary contact for investigators and authorities, ensure alignment of site start-up activities with submission timelines, maintain trial status databases, oversee country study files, advise on out-of-scope contract activities, mentor team members.
Seniority
Senior, hands-on IC with mentorship responsibilities
