Director, Regulatory Affairs - Global Filing Lead

Revolution Medicines

Redwood City, United States
$211,000—$264,000 usd py
On-site
Global regulatory nda/maa filings
Oncology drug development
Health authority interactions
Revolution Medicines is seeking a Director of Regulatory Affairs to lead global NDA/MAA filings for their late-stage oncology programs. The ideal candidate will have extensive experience in oncology drug development and regulatory strategy, along with strong leadership skills

Job Summary

  • The Director of Regulatory Affairs (Global Filing Lead) is accountable for driving preparation & execution of global regulatory NDA/MAA filings for late-stage oncology programs at RevMed.
  • They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.
  • The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA & global filing regulations, current Health Authority thinking, and have strong leadership & problem-solving ability.

Matching Summary

Match Score: 87

Revolution Medicines is seeking a Director of Regulatory Affairs to lead global NDA/MAA filings for their late-stage oncology programs. The ideal candidate will have extensive experience in oncology drug development and regulatory strategy, along with strong leadership skills.

Salary

$211,000—$264,000 USD

Skills & Requirements

Must-have

  • global regulatory NDA/MAA filings
  • oncology drug development
  • Health Authority interactions
  • CTD structure management
  • cross-functional coordination

Nice-to-have

  • APAC and access consortium countries
  • problem-solving ability
  • mentoring direct reports

Key Requirements

  • 12 years pharmaceutical/biotech industry experience
  • 8 years Regulatory Affairs experience
  • Proven success in global NDA/MAAs
  • Experience with expedited filing pathways
  • Direct experience in oncology drug development

Work Rights

Not specified

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