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Oruka Therapeutics

Biologics Regulatory CMC Director — Hybrid & Equity

waltham, MA

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About this opportunity

Oruka Therapeutics lists this Biologics Regulatory CMC Director — Hybrid & Equity opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.

Job description

A biotechnology company based in Waltham, Massachusetts is looking for a Director / Senior Director, Regulatory CMC. This role involves owning the global regulatory CMC strategy, leading submissions aligned with FDA and EMA guidelines, and fostering collaboration across teams. Candidates should have a minimum of 10 years in biologics CMC roles and a strong track record in drug substance development and regulatory submissions. The position offers a competitive salary between $213,000 and $286,000 plus a benefits package and a hybrid work model.

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Worksite address

waltham, MA, 02254, US

Who can apply

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