Performs validation document generation, program management, and protocol execution activities. Interface with Engineering, and end user groups to support development of life cycle documents and system requirements. Design the validation approach with technical oversight, provide the scientific rationale and acceptance criteria, and generate validation protocols. Execute

will include, but are not limited to, the following 1. Participate in the development of the CMC regulatory strategy for post approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collab