Regulatory and Start‑Up Specialist

About the role

This position supports site activation activities at a country level, ensuring compliance with local and international regulations, SOPs, and project requirements. The role is home‑based and serves as the single point of contact for investigative sites and internal teams.

Key responsibilities

• Act as Single Point of Contact (SPOC) for assigned studies, coordinating with sites, Site Activation Managers, and project teams.
• Perform start‑up and site activation tasks according to regulations, SOPs, and work instructions.
• Prepare, review, and distribute regulatory documents, ensuring completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with project‑specific information.
• Monitor site performance metrics and provide feedback to management.
• Track and follow up on approval and execution of regulatory, ethics, ICF, and Investigator Pack documents.
• Provide local regulatory expertise during project planning and timeline development.
• Conduct quality control of documents submitted by sites and may liaise directly with sponsors on specific initiatives.

Required profile

• Experience in regulatory and site activation activities within clinical research.
• Ability to work under general supervision and manage multiple stakeholder relationships.
• Strong attention to detail for document review, tracking, and quality control.
• Proficiency in maintaining internal databases and tracking tools.
• Capability to monitor project timelines and implement contingency plans as needed.