R&D Regulatory Manager Position Available In Androscoggin, Maine

R D Regulatory Manager at Grifols Shared Services North America, Inc in Lewiston, Maine, United States Job Description Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

Primary responsibilities:

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies. + Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions. + Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business. + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans. + Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements. + Writes documents with complex scientific information for regulatory submissions. + May supervise staff + May have responsibility for maintaining