Celanese is looking to ensure the safety and regulatory compliance of chemical products across global markets
Requirements
- DABT (Diplomate of the American Board of Toxicology) or equivalent certification in toxicology or directly related field
- Strong understanding of human health risk assessment concepts and methods, with some familiarity with environmental risk assessment (preferred but not required)
- Deep knowledge of international toxicological regulations and guidelines, including FD&C, REACH, OECD, and ICH
- QSAR analysis
- Read-across assessments
- Toxicology data gap analyses
Responsibilities
- Expertise on required mammalian toxicology studies for chemical evaluation, food contact, and biocompatibility and human health risk assessments to comply with relevant toxicological regulations (e.g., FD&C, REACH) and guidelines (e.g., OECD, ICH)
- CRO selection and oversight for complex toxicology studies requested for chemical evaluation
- Preparation of regulatory filing dossiers in the US, EU, and Japan (chemical evaluation, food contact, drug master files)
- Assessing impurities levels in the manufacturing process to characterize potential hazards and risks
- Perform toxicology data gap analyses, QSAR analysis, develop read-across assessments and assess potential risks to human or animal health and the environment
- Writing toxicology study waiver requests
- Provide expert scientific advice and guidance to respond to regulatory inquiries in the chemical industry
Other
- Bachelors degree required. Masters or Ph.D preferred in Toxicology, Pharmacology, Environmental Health Sciences, Chemistry, Chemical Engineering or related discipline
- At least 7-10 years of experience in a regulatory environment preferred
- Strong interpersonal and collaboration skills in an international working environment
- Personal development to maintain a high level of toxicological expertise and applying that expertise to meet regulatory and safety objectives that align with Celanese’s annual objectives
- Demonstrated ability to solve complex scientific and regulatory problems
