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FDA's Office of New Drugs

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Pharma/Tox Senior Consultant (Remote)
Biologics Consulting is seeking to hire an expert regulatory toxicologist.   This position involves working as a consultant directly with biopharmaceutical companies to advise them on the best pharmacology/toxicology approaches that will expedite moving their products into the clinic and through marketing authorization.  Responsibilities include, but are not limited to planning appropriate pharmacology-toxicology studies, interfacing with toxicology CROs, preparation for and participation in FDA meetings, evaluation of toxicology data, and reviewing and/or writing regulatory documents (pre-IND briefing packages, IND, BLA/NDA). This is a full-time, salary, plus performance based bonus position. Biologics Consulting is a full-service regulatory and product development


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