Risk Assessment and Regulatory Affairs Scientist

Company: Gad Consulting Services
Location: Raleigh
Posted on: November 26, 2022

Job Description:

_Who we are: _Gad Consulting Services, located in Raleigh, North Carolina, has been providing toxicology and regulatory consulting services to the drug and medical device industry for over 28 years. We have successfully served the needs of more than 600 client firms from around the world in the fields of pharmaceutical development and regulation, risk assessment, and medical device development. We are a small company, and the increasing need for these services has led us to continually grow through adding to our team. We are looking for a scientist with a background in GLP toxicology, drug and device regulatory development, and/or risk assessment, who also exhibits strong writing skills._Key Responsibilities: _ Perform literature searches to identify reliable and robust health hazard information on chemicals. Conduct hazard and toxicological reviews, summarize and interpret the information. Write reports / prepare human health risk assessments based on chemical data. Be able to write in a way that can be read and understood by a wide audience including regulators and industry with both science-based and non-science-based backgrounds. Deliver toxicological risk assessment reports on extractables, leachables, excipients, and impurities from raw materials, component parts, and finished products. Prepare assessments/plans/reports as the supporting documentation to demonstrate the acceptability of drug formulation or materials for pharmaceuticals and medical devices based on the relevant patient exposure. Estimate toxicity of chemical structures by using Quantitative Structure-Activity Relationship ( Q SAR) modeling. Communicate effectively (verbal/written) and professionally with all levels of personnel both internal and external._Qualifications: _Bachelors, Masters, or PhD in toxicology, environmental toxicology, pharmacology, pharmaceutical sciences, public health, biomedical engineering, or related discipline.The following skillsets are desired/would be a "plus": Experience in regulatory or toxicological risk assessment or related fields. Experience in conducting risk assessment. Experience with Computational Modelling, Quantitative Structure-Activity Relationships (Q)SAR methods and software such as DEREK._Skills: _ Able to work independently or as part of a team Willing to continuously learn and apply new skills and adapt to changing regulatory landscape Excellent time management and organizational skills Able to efficiently understand and help client's define their needs and present a sound solution supported by documented scientific data Fluency in the Microsoft Office suite.Gad Consulting Services offers an excellent benefits package, as well as a heavily emphasized and supported professional development program. Training is provided.Location: Raleigh, North CarolinaJob Type: Full-timePay: $45,000.00 - $85,000.00 per yearBenefits: 401(k) Dental insurance Health insurance Life insurance Paid time off Parental leave Vision insuranceSchedule: 8 hour shiftCOVID-19 considerations:To keep our employees as safe as possible, we are working a hybrid schedule.Education: Bachelor's (Preferred)Work Location: One location

Keywords: Gad Consulting Services, Raleigh , Risk Assessment and Regulatory Affairs Scientist, Other , Raleigh, North Carolina