QA Regulatory Compliance Specialist
Nitto Denko Avecia
This is a Contract position in Washington, DC posted October 19, 2021.
Purpose of the Position:The Regulatory Compliance Specialist will support compliance initiatives at the Milford an Cincy sites, and will work closely with the Directors and VP of Quality & Regulatory.
This position will have no direct reports.Key Job Responsibilities:The person in this role will create and update Facility Document Manufacturing Files (DMFs) and Site Master Files.The person in this role will also assist with client Regulatory requests, and may review client IND, NDA sections for accuracy.This person will review and process client Quality Agreements, and will handle site FDA registrations.Support development of CMC sections, of IND, NDAs BLAs, experience with negotiating and developing quality agreements.Additional responsibilities may apply.Job Knowledge Required:3-5 years experience in the Regulatory field in the pharmaceutical/biotech industry with quality or regulatory experienceExcellent written and verbal communication skillsStrong knowledge of GMPExperience Writing DMFs
