Senior Manager GRA CMC Combination Product and Stand Alone Medical Device Specialist
CSL
CSL is seeking a Senior Manager, GRA CMC – Combination Product and Stand‑Alone Medical Device Specialist to lead global CMC regulatory strategy for drug‑device combination products and medical devices. In this role, you will design and execute CMC regulatory plans, author and review high‑quality submissions, and ensure alignment with global requirements for combination products and devices. Partnering with R&D, quality, manufacturing, and clinical teams, you will guide integration of device and drug requirements, manage change control, and interact with health authorities worldwide. You will monitor regulatory trends, shape internal best practices, and mentor junior staff while contributing to CSL’s mission of delivering innovative, life‑saving therapies in a collaborative, science‑driven environment.
Vacancy posted 8 days ago
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