Thomas N. Email & Phone Number

This role provides technical/project leadership across regions, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. The role also provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements, and acts as liaison with internal and external clients in the provision and marketing of these services.Responsibilities: Provide senior review and advice to prepare regional regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity.Provides internal clients with up-to-date legislation and guidance as it becomes available.Ensure quality performance for key/managed projectsManage project budgeting/forecasting functions.Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modifications.Collaborate with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budget in collaboration with other departments.Provides matrix/project leadership, training and guidance to junior team members.Ensure compliance with relevant organizational and regulatory SOPs and WPDs.Participate in launch meetings, review meetings and project team meetings.