Regulatory Affairs Contractor – Georgia

About the role

This contractor position supports the regulatory and legal aspects of site activation for clinical trials. You will work closely with cross‑functional teams to ensure rapid study start‑up and compliance with global and local requirements.

Key responsibilities

• Coordinate feasibility questionnaires, liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs and sponsors to enable fast trial start‑up.
• Support business development by reviewing proposals, costing, and participating in bid meetings.
• Manage regulatory activities: prepare, track and submit regulatory dossiers, conduct translation reviews, perform local quality checks, and communicate status to project teams.
• Negotiate Confidential Disclosure Agreements (CDAs) and ensure compliance with country‑specific regulations.
• Maintain regulatory intelligence, advise on strategies, and update teams on legislative changes.

Required profile

• Strong knowledge of global and local regulatory and legal requirements for clinical trial site activation.
• Experience in feasibility assessment, business development support, and regulatory submission processes.
• Familiarity with ICH GCP, SOPs and applicable regulations.
• Ability to identify risks, propose mitigation strategies, and communicate effectively with internal and external stakeholders.

Required skills

What we offer

• Opportunity to work on international clinical trial projects.
• Collaboration with multidisciplinary teams across the organization.
• Exposure to regulatory intelligence and strategic business development.