Regulatory Affairs Contractor – Serbia

About the role

This contractor position supports RSU Global in managing regulatory and legal requirements for clinical trial site activation in Serbia. The role combines feasibility analysis, business development support, and regulatory submission activities to ensure rapid trial start‑up and compliance with local regulations.

Key responsibilities

• Coordinate feasibility questionnaires, liaise with clinical monitoring, contracts, and regulatory affairs, and obtain sponsor and client approvals.
• Negotiate and review Confidential Disclosure Agreements (CDAs) according to country‑specific requirements.
• Support business development by reviewing proposals, costing, and participating in bid meetings.
• Plan, compile, track, and submit regulatory dossiers; provide local quality control and translation review.
• Communicate submission status, identify risks, and develop mitigation strategies.
• Maintain regulatory intelligence, advise project teams on strategies, and ensure compliance with SOPs, ICH GCP, and local regulations.

Required profile

• Experience in clinical trial start‑up, feasibility assessments, and regulatory affairs.
• Strong understanding of ICH GCP, SOPs, and country‑specific regulatory requirements.
• Excellent communication and negotiation skills with internal and external stakeholders.

Required skills

• Regulatory submission preparation and review.
• CDA negotiation and documentation.
• Feasibility questionnaire development.

What we offer

• Opportunity to work on international clinical trial projects.
• Exposure to cross‑functional teams in a global environment.
• Contract‑based engagement with flexible working arrangements.