Associate Regulatory and Start-Up Manager - Hungary

About the role

The Regulatory & Site Activation Manager leads the delivery of site activation, regulatory and maintenance activities for assigned clinical studies and programs. The role ensures projects are delivered on time, within scope and in compliance with regulatory requirements, while providing leadership, strategic oversight and support to study teams and clients. The position is based in Budapest.

Key responsibilities

• Lead site activation, maintenance and regulatory activities for assigned studies
• Develop and oversee project plans, timelines, budgets and resources
• Provide regulatory strategy and guidance for study start-up and ongoing maintenance
• Identify risks and regulatory challenges and implement effective solutions
• Collaborate with global, regional and country teams to ensure successful project delivery
• Support business development activities, including proposals and bid defenses
• Ensure compliance with quality standards, regulatory requirements and internal processes
• Mentor and support team members, driving performance and development
• Maintain accurate project documentation, systems and tracking tools

Required profile

• Bachelor's degree in a relevant Life Sciences or Healthcare field
• Minimum 3 years of clinical research experience, including at least 1 year in a leadership or project management capacity
• Excellent communication, stakeholder management and presentation skills
• Proven ability to manage multiple priorities, lead teams and work independently
• Strong organisational skills, attention to detail and problem-solving abilities