Responsibilities

The Regulatory Affairs Lead will serve as a subject matter expert, providing strategic regulatory advice to both internal and external clients on projects of moderate complexity, ensuring compliance with local, regional, and ICH regulatory requirements. They will review regulatory documents and submissions, act as a liaison with internal and external clients, and provide guidance on product development from preclinical through registration. The role involves leading junior team members, participating in project management activities, and ensuring adherence to project budgets and timelines. Additionally, the Lead will monitor and interpret changes in legislation, deliver training, and advise on regulatory risk mitigation strategies.