Senior Specialist Study Start Up & Regulatory Affairs
Core
Leads study start-up and regulatory activities to achieve site initiation readiness for clinical trials in medium-complexity, multi-country environments.
Role type
Senior Specialist Study Start Up & Regulatory Affairs
Builds
Study start-up plans, regulatory submissions, essential documents, and clinical site agreements
Domain
Clinical research / Pharmaceutical / Rare disease and oncology
Required skills
ICH-GCP knowledge, multi-country regulatory compliance, clinical site agreement negotiation, document translation coordination, risk escalation, budget monitoring, SOP development, audit support, mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead preparation, review, and quality control of regulatory and study start-up documentation; draft, negotiate, and execute clinical site agreements and amendments; coordinate with study teams, sponsors, and monitoring on document processing for investigational product release; act as country/regional subject matter expert for regulatory and CSA elements; provide strategic input on regulatory strategy and SSU plans; identify and escalate project risks; monitor project budgets and hours; support junior members in audit/inspection preparation; contribute to SOP design and provide training/mentoring.
Seniority
Senior, hands-on IC
