Regulatory Specialist – Chemistry, Manufacturing, and Controls (CMC)

sutrobio

2 months ago

South San Francisco, CA

Onsite

Full Time

Junior

0 applicants

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About this role

Sutro Biopharma is looking for a Regulatory Associate to support the development and lifecycle management of their oncology portfolio, focusing on regulatory documentation and compliance related to clinical trials and product approvals. The role involves collaborating with cross-functional teams and maintaining regulatory files to ensure adherence to global standards.

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About sutrobio

sutrobio.com

Sutro Biopharma is a clinical-stage biotechnology company based in South San Francisco that discovers, develops, and manufactures protein therapeutics for cancer and autoimmune diseases. It leverages an integrated cell-free protein synthesis platform, XpressCF, to design and produce modalities including cytokine-based immuno-oncology agents, bispecific antibodies, and antibody–drug conjugates (ADCs). Its lead ADC candidates, STRO-001 (anti‑CD74 for multiple myeloma and non‑Hodgkin lymphoma) and STRO-002 (anti‑folate receptor‑α for ovarian and endometrial cancers), are engineered with site-specific linker–warhead placement to optimize therapeutic index. Sutro focuses on directing potent modalities at clinically validated targets to accelerate translation from discovery through manufacturing.