Requirements
Bachelor Degree in any Pharmacy, Medicine / Veterinary Medicine, Science.Good command of English language (written and spoken).Proven experience in Regulatory affairs with min of 0 - 2 years’ experience.Current or previous experience in CMC is a plus.MS Office Suite: Advanced userERP software: Basic userKnowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
Description
Complete renewal & exist products’ registration process at MOH.Provides direct assistance with the registration of new and existing products in markets supplied by the plant.Prepares and submit files and reports to related regulatory authority.Coordinate & follow all steps of registration in EDA (Egyptian Drug Authority) including Stability Study, Bioequivalence Study, Inserts, Packs and NODCAR files till approval.Follows up batches and raw material submitted samples for analysis till receiving conformity.Implement and follow up any variations needed in any product such as change in pack, formula …….etc.Submit and Follow up and any supporting documents along with registration lead time.Track the application deadline updates and gathers the required documentation from related parties.Coordinate & collaborate with the R&D, Q.C, Production, Marketing team members.Communicate regulatory information to multiple departments.Maintains current knowledge of updated regulatory guidelines.Establish and maintain professional relationships with the internal and external stakeholders.Implement and maintain registration tracking system for publishing document submissions either in hardcopy or electronic formats.Resolve or follow up complaints to ensure effective and timely resolution of all complaint investigations.Notifies direct manager when compliance issues arise or are identified, when regulatory reports are delayed, and when other immediate action is required.Archiving all documents, licenses and letters.