About the Role
Description
Summary:The Principal Toxicologist will prepare Toxicological Risk Assessments (TRAs) across diverse projects supporting R&D, CMC, and Quality, ensuring alignment with global regulatory standards and may author nonclinical submission documents. A key responsibility is the rapid evaluation of unexpected manufacturing, release, or stability deviations to support decisions on patient safety, product quality, and business continuity.
This global role requires strong cross‑functional collaboration and engagement with external experts, including participation in worldwide project teams and assessment meetings.
Main Responsibilities:
Organize, prepare, and peer-review toxicological risk assessments supporting R&D projects and Quality initiatives.
Apply advanced toxicological principles—including literature evaluation, SAR/read‑across methodologies, and health‑based exposure limit setting (e.g., PDE/ADE, AI, OEL, TE, TTC)...
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