Regulatory Strategy Leader, Oncology — Senior Director

EPM Scientific

Hayward (CA)

In loco

USD 240.000 - 320.000

Tempo pieno

15 ore fa

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Descrizione del lavoro

EPM Scientific is supporting a clinical-stage oncology biotech seeking a Senior Director of Regulatory Affairs. This leader will build regulatory strategy from development to commercialization and manage major filings with FDA, EMA, and global health authorities.

The role requires senior leadership, cross-functional collaboration, and a proactive regulatory posture to advance a robust oncology pipeline. The position offers ownership, visibility to senior leadership, and a chance to shape

Competenze

Advanced degree with 12+ years in regulatory affairs, or a Bachelor's degree with 15+ years; PhD or PharmD preferred.
Proven record leading submissions and direct FDA interactions.
Oncology regulatory experience strongly preferred.

Mansioni

Develop and carry out regulatory strategy from development through approval and commercialization
Lead preparation and submission of major filings (IND, NDA, MAA)
Serve as a primary contact with FDA and global health authorities, and prepare teams for and lead agency meetings
Act as the strategic regulatory partner to R&D, Clinical Development and Quality
Spot regulatory risks early and put proactive mitigation plans in place
Keep up to date on changing FDA and international requirements and keep the company compliant (GCP/GLP)
Build, mentor and scale the regulatory team as the pipeline advances