17548 RA Manager
・Responsible for providing submission managing for all NDA applications.
・Responsible for interfacing with project managers, regulatory leaders, and/or content authors to discuss planned submission preparation.
・Liaise with functional source areas (Clinical, Nonclinical, CMC) to ensure documents are compliant and submission ready. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
・Identifies regulatory risks and emerging issues and proactively develops mitigations and solutions.
・Ensures that all regulatory content and information is appropriately tracked, archived, searchable, and accessible.
・Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the PMDA.
・Responsible for the creation, assembly, and publishing of routine CTD submissions.
・Adherence to required submission timelines, health authority publishing specifications, and internal working practices.