Senior Country Approval Specialist---Startup Lead
Core
Manages the preparation, review, and coordination of country submissions for clinical trials, ensuring alignment with global strategy and regulatory guidelines.
Role type
Senior Country Approval Specialist (Clinical Trials Regulatory)
Builds
Regulatory submission packages and country-specific study files for clinical research projects.
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory guideline knowledge, submission strategy development, stakeholder coordination, document preparation, contract review, feasibility coordination, data maintenance, SOP compliance, mentorship
Preferred skills
Medical/therapeutic area knowledge, negotiation skills, digital literacy
Technologies
PPD WPD database, internal submission systems
Responsibilities
Prepare and review country submissions (MoH, EC, safety dossiers, import licenses); develop and implement local submission strategies; serve as primary contact for investigators and local authorities; coordinate site start-up activities and feasibility; maintain accurate trial status information in the database; oversee country study files; advise and mentor team members; identify and resolve regulatory process anomalies.
Seniority
Senior, hands-on IC with mentorship responsibilities
