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Manager, Regulatory Affairs at Adicet Bio - ApplyBlast

Manager, Regulatory Affairs

Adicet Bio

1 month ago

3.4 on Glassdoor

Redwood City, California, United States

Hybrid

Full Time

Manager

0 applicants

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About this role

The Manager, Regulatory Affairs at Adicet Bio will lead global CMC regulatory implementation for cell therapy projects, overseeing preparation and filing of submissions and supporting clinical and nonclinical regulatory activities. The role reports to the Regulatory group and requires extensive experience with FDA and international submissions in biotechnology.

Responsibilities

Manage preparation and filing of regulatory CMC submissions
Support global CMC regulatory timelines and milestones
Develop meeting materials and briefing books for FDA and ex‑US agencies

Skills

Qualifications

BS in Life SciencesAdvanced degree

About Adicet Bio

adicetbio.com

Headquarters

Redwood City, California, United States

Company Size

51-200 employees

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Adicet Bio is a clinical-stage biotechnology company developing off-the-shelf, allogeneic gamma delta T cell therapies for cancer and autoimmune diseases. Their proprietary platform engineers Gamma Delta 1 CAR T cells to enable novel targeting, tissue homing, and improved drug exposure with the goal of delivering best-in-class, on‑demand cell therapies. Adicet advances a pipeline of engineered cell therapy candidates and provides regular clinical and investor updates from offices in Redwood City, Boston and Shanghai.