Associate director, cmc regulatory affairs (hematology/oncology)
DublinRegeneron Pharmaceuticals
...to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.* Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, [...]
Category Management & Consulting