Associate Director / Director, Regulatory Affairs – IHC Companion Diagnostics (CDx)

Systimmune

26 days ago

Redmond, WA

Onsite

Full Time

Director

0 applicants

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About this role

SystImmune is seeking a Regulatory Affairs leader to oversee FDA interactions for IHC-based Companion Diagnostics within their oncology pipeline. This role involves leading regulatory strategy, developing teams, and ensuring high-quality submissions to support the company's innovative cancer therapeutics.

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About Systimmune

systimmune.com

SystImmune is a Redmond, WA–based biopharmaceutical company developing bi‑specific and multi‑specific antibodies and antibody‑drug conjugates (ADCs) to treat cancer. Its mission is to create biologics that both directly attack tumors and activate the immune system to enhance anti‑tumor responses, using proprietary protein‑engineering and antibody‑discovery platforms. A multidisciplinary team across the U.S. and China focuses on rapid, cost‑efficient clinical development. SystImmune is a member of the Biokin Pharmaceutical group and partners with Bristol Myers Squibb and OrbiMed, and it is seeking additional collaborators to develop and commercialize its therapies worldwide.