Regulatory CMC Manager

2 days ago

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Orca

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Description

• More than one million people in the United States today are fighting blood cancer. • Orca Bio is a late-stage biotechnology company redefining the transplant process. • The Regulatory CMC Manager will be responsible for authoring and preparing regulatory packages. • The successful candidate will support the development and execution of regulatory strategies. • This role requires a strong scientific background with experience in cGMP manufacturing. • The successful candidate will work cross-functionally to ensure regulatory submissions meet objectives.

Requirements

• Bachelor’s degree (or equivalent) in life sciences; advanced degree preferred. • 5+ years of experience in the biotech/pharmaceutical industry. • 4+ years of experience in CMC regulatory affairs within pharma or biotech, preferably within cell therapies. • Knowledge of cGMP, CMC regulatory requirements, both domestic and global. • Strong scientific writing skills, with an emphasis on preparing high-quality regulatory packages (BLA/late stage submissions preferred). • Ability to work effectively in cross-functional teams with a collaborative and hands-on approach. • Initiative-taking and able to manage multiple tasks independently. • Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.