Global CMC Regulatory Lead — Devices

Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexion’s drug/device portfolio, in‑vitro diagnostics and clinical decision software. This role leads complex...

Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexion’s drug/device portfolio, in‑vitro diagnostics and clinical decision software. This role leads complex...

Position Summary Do not wait to apply after reading this description a high application volume is expected for this opportunity. The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to...

A leading biopharmaceutical company in Boston seeks an Associate Director of Global Regulatory Affairs to manage CMC regulatory strategies for various products. The ideal candidate will have at least 6 years of Device Regulatory experience, a relevant scientific degree, and strong communication skills. This role involves strategic collaboration and...

GRA Chemistry Manufacturing & Controls (CMC) And Devices Organization RoleAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. This role is within the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's...

Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexions drug/device portfolio, invitro diagnostics and clinical decision software. This role leads complex projects...

GRA Chemistry Manufacturing & Controls (CMC) And Devices OrganizationAt Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring...

Position Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRACMC) Devices and Combination Products plays a pivotal role in implementation of global CMC regulatory strategies related to Alexions drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and...

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Regulatory Affairs Manager, CMC - Biologics (Phase 3 Asset | Advanced Modality)Boston area (hybrid, flexible travel)I'm currently searching for a Regulatory Affairs professional looking to take ownership of a late-stage biologic program.This is an opportunity to join a cutting-edge biotech advancing an autoimmune Phase 3 asset and play a pivotal role in...