Regulatory Site Officer

Job Description :

• Preparing Registration Dossiers (Technical Part) for new product, product with expired visa number, product with changes
• Updating or modifying the Site Master File
• Managing the application of the registration dossier to the Production and QC activities, ensuring the compliance.
• Defining the new requirements in terms of technical dossiers for each item or group of product in case of a new registration regulation, or of a new VN Pharmacopoeia.
• Controlling of the transfer document when technique handover.
• Check the text of the new packaging material artworks according to the approved registration ones.
• Update data requested by the IRCC Compliance Operations Management e-Room
• Participate and support in HSE activities in plant

• University graduated in Pharmacy or Biology
• 2- years experience in pharmaceutical production and quality control
• Intermediate En...