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Associate Director, Preclinical Toxicology
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Full-time
- Your Role: The Associate Director o f Preclinical (Toxicology and biocompatibility) will support a portfolio of drug, medical device, drug packaging system, and/or combination product development and global registration.
- This individual will apply expertise and in-depth applied knowledge of toxicology, biocompatibility, and related scientific knowledge to find innovative solutions to develop nonclinical regulatory strategies, solve technical challenges and move new product development and product support projects forward.
- The role will report to Director of Preclinical and Toxicology assessment team responsible drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries).
- Independently develops and authors preclinical regulatory submission content for CTD and DHF files, US FDA, EU and other national or global submissions.
- Independently develops and authors responses to submission deficiencies/questions (e.g., 510K, PMA, EU MDR).
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