Associate director cmc regulatory affairs
DublinRegeneron Pharmaceuticals
...to mitigate risks to filings; find alternative solutions/workarounds and secure interpersonal consensus. Critically review and provide strategic feedback on regulatory documents (e.g., IMPDs, meeting packages, scientific advice, MAAs, quality defect assessments, Notified Body Opinions) to expedite development, licensure, and [...]
Category Management & Consulting