Regulatory and Start-up Manager

Responsibilities

• Lead and manage site activation, maintenance, and regulatory activities for clinical studies and multi-protocol programs
• Oversee the execution of site activation and maintenance in accordance with agreed strategies and project timelines
• Develop, implement, and maintain management plans according to the scope of work and project plan
• Provide specialist regulatory and technical scientific support to facilitate efficient business development and study initiation
• Determine regulatory strategies, expectations, and parameters for submissions and necessary authorizations
• Identify regulatory complexities and propose creative, practical solutions to support the bid process and execution
• Review the regulatory landscape and disseminate accurate regulatory intelligence to support assigned studies
• Collaborate with Quality Management to ensure appropriate quality standards are maintained throughout the project lifecycle
• Mentor and coach colleagues and maintain accurate internal systems, databases, and tracking tools

Requirements

• Bachelor's Degree in Life Sciences or a related field
• 7 years of relevant experience in a scientific or clinical environment
• Demonstrable experience in an international role
• Strong knowledge and ability to apply GCP (Good Clinical Practice) and ICH guidelines
• Proven expertise in the regulated clinical trial environment and drug development process
• Excellent technical and regulatory writing skills
• Strong negotiation, communication, and leadership skills
• Ability to manage multiple projects and balance competing priorities

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.