Regulatory Affairs Specialist

Job Description

• Identify, prepare, and submit New Product dossiers/files to the Egyptian Drug Authority “EDA” as per the legislative guidelines.
• Handle the re-registration process of products licenses by preparing and submission of the required documents to EDA.
• Prepare and submit products analysis files to EDA and follow the analysis process with concerned authorities.
• Handle the registered products variation analysis with the concerned governmental health authorities.
• Review all technical documents received from different internal departments (e.g. Quality, R&D, etc) and assure it fulfils the legislative requirement for the product registration process.
• Assure timely delivery of activity reports on regular basis to The Regulatory Affairs with detailed progress of different products files.
• Prompt and proper response for all queries & deficiencies of submitted documents and ensures timely submission of all additionally requested documentation.
• Keep updated knowledge of legislative and regulatory guidelines related to products registration protocols.
• Assure timely delivery of activity reports on regular basis to The Regulatory Affairs head with detailed progress of different products files.

Job Requirements

• Bachelor’s degree in Pharmacy is a must.
• 1 - 4 years of experience in similar job duties in the pharmaceutical industry.
• Previous in-depth experience in dealing with the concerned Egyptian health authorities.
• Good Knowledge of regulatory affairs rules, processes, and procedures in the pharmaceutical Industry.
• Good understanding of products files preparation and submission process.
• Proficient computer skills including MS Office Applications.
• Previous experience with SAP systems is preferred.
• Excellent communication skills and ability to build a network of connections.
• Fluency in the English language.
• The initiative, Hard Worker and Team Player.