Director of Regulatory Affairs

4 weeks ago


South San Francisco, United States Trebla Talent Full time

Role:

Director, Regulatory Affairs

Bay Area/Hybrid


Company Description:

This precision oncology biotech is advancing next-generation targeted therapies. Having recently emerged from stealth mode with substantial funding, this pre-IPO company is pioneering new frontiers in antibody engineering and its working Their innovative approach has already earned FDA Fast Track Designation for their lead indication and a promising future


Role Description:

This position will be responsible for developing and executing regulatory strategies for early-phase programs and IND submissions. This person will serve as the primary contact with the FDA to negotiate and orchestrate all health authority interactions


Qualifications:

10+ years of relevant experience in Biotech/Pharma

Prior experience with FDA submissions is required.

IND experience is wanted

Oncology experience is a plus

8+ years in Regulatory Affairs


If you are interested in this position, please apply here and email me: natalia.pj@treblatalent.com



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