Principal Reg Affairs Specialist - Global Support

The Principal Reg Affairs Specialist will lead regulatory support for multiple countries and projects, providing strategic regulatory intelligence and guidance for product development from preclinical stages through optimization. This role involves serving as a subject matter expert, offering regulatory strategy advice, and acting as a liaison with internal and external clients for service provision and marketing. Responsibilities include performing senior reviews of regulatory documents and submissions, ensuring adherence to quality standards and regulatory requirements, and participating in project management activities. The specialist will also provide leadership, training, and guidance to junior team members, manage project budgets, timelines, and scope, and ensure compliance with SOPs and WPDs. Contributions to business development, including project budgeting and forecasting, are also expected.