Amgen Regulatory Affairs CMC in São Paulo, Brazil
Affairs Manager to coordinate timelines and submission expectations.
Execute and plan timelines to answer responses to ANVISA requests.
Follow QA/QC testing schedules for pipeline products to know when to receive and review documentation for accuracy and quality.
Consult with PE and stability group on preparing documentation for testing and agree on timeline.
Ensure technical team is up to date on the trainings regarding: Regulatory, Quality testing, Validation updates as well as updates to analytical methods based on ANVISA requirements. Ensure training record incorporates these needs.