Senior Regulatory and Start Up Specialist - South Africa
Core
Manage site identification, regulatory submissions, ethics approvals, and site activation activities to accelerate clinical trial start-up.
Role type
Senior Regulatory and Start Up Specialist (Clinical Research)
Builds
Clinical trial start-up and site activation for pharmaceutical and biotechnology sponsors
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Clinical trial regulatory affairs, site start-up, site activation, local and international regulatory requirements, GCP, contract management, regulatory documentation management
Preferred skills
None stated
Technologies
None stated
Responsibilities
Serve as primary point of contact for investigative sites and stakeholders; Execute site identification, feasibility assessment, and activation; Prepare and review regulatory documentation for compliance; Track and manage submissions for ethics committees, ICFs, Investigator Packs, and CTAs; Negotiate and manage site contracts and deliverables; Monitor project milestones and risks; Provide local regulatory expertise to project teams; Perform quality reviews of site documentation.
Seniority
Senior, hands-on IC
