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.