• 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.

Desired Candidate Profile

• Bachelor Degree in Pharmacy. • Good command of English language ( French is a plus). • Proven experience in Regulatory affairs with min of 2 3 years experience. • Current or previous experience in CMC is a plus. • MS Office Suite: Advanced user • ERP software: Basic user • Knowledge 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.