Ann-Kristin Spiik

Principal Consultant, Drug Development

Ann-Kristin Spiik is Principal Consultant, Drug Development, at Cytel, based in our Stockholm office. Ann-Kristin is a dedicated and flexible project manager with extensive knowledge and experience in various facets of drug development. As a Senior Consultant in Chemistry, Manufacturing, and Control (CMC), she helps to oversee and guide the development, manufacturing, and testing processes of drug substances and drug products to ensure product quality and compliance with regulatory requirements. Over her 20+ year career, she has worked across different sectors of the industry, from early academic spin-offs to established pharmaceutical companies with mature projects. Her diverse functional responsibilities have included research, strategic planning, CMC project management, developing CMC strategies, overseeing clinical supplies, and quality assurance management. Additionally, Ann-Kristin is experienced in preparing regulatory documents and has actively participated in face-to-face meetings with multiple regulatory agencies.