Internal validation protocols, dossier drafting history, deviation and change-control records, training material she wrote, and a letter from the technical director connecting each item to the work planned in the United States.
Use the company's own archive, then explain each piece
Hypothetical example: the quality system holds every version of the company's stability protocols, the change-control record for each submission and the internal course she built for new regulatory staff. Export the documents she authored or maintained, the submission history showing her role, and the internal registers listing who has access to which files. Add the technical director's letter tying each document to a specific task at the American affiliate, because a reviewer should not have to guess why a protocol matters.
Include the corporate ownership records and payroll for the qualifying year in the same file, since they are tested at the same time. Redact genuine confidential material where needed but leave enough that the knowledge is visible. Material describing general regulatory practice, or industry guidance available to anyone, weakens the file rather than strengthening it.