Execute regulatory strategies by leading the development, authoring and review of Chemistry, Manufacturing and Control submission components and documentation to support approval supplements/variations, Drug Master Files, New Drug Application/Biologics License Application/Marketing Authorization Application, Annual Reports, Commitment and responses to health authority questions. This Role is responsible for developing and implementing Chemistry, Manufacturing and Control regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies, in addition to the preparation and review of information required for development of regulatory Chemistry, Manufacturing and Control dossiers for commercial products.