Global Regulatory Affair Manager

The Global Regulatory Affairs Manager will coordinate global regulatory strategies for clinical trials, studies, and projects, providing technical and project leadership across regions. Responsibilities include offering strategic regulatory intelligence and guidance for product development, preparing client deliverables that meet regulatory requirements, and acting as a liaison with internal and external clients. The role also involves representing the regulatory department, supporting business development, working on initiatives, contributing to quality improvement, and arranging and leading client and regulatory agency meetings. Key duties include leading global regulatory submissions, acting as a subject matter expert for regulatory strategy advice, providing clients with updated legislation, ensuring quality performance, managing project budgets, identifying out-of-scope activities, collaborating on pricing and new business, providing leadership and training to junior team members, ensuring compliance with SOPs and WPDs, and participating in various project meetings.