Regulatory Affairs Officer job description

About the job

We are looking for a regulatory affairs officer to register medicines and medical products with the Libyan regulatory authorities and keep registrations up to date, making sure every product the organization imports or distributes meets the requirements before it reaches the market.

Duties and responsibilities

• Prepare registration dossiers for medicines and medical products in the required format, such as CTD
• Submit dossiers to the regulatory authority and follow them through to approval
• Answer the regulator's queries and supply additional documents, working with the manufacturer
• Track registration renewals and submit variations when the product, pack or manufacturing site changes
• Review leaflets, packs and labels and check they meet requirements, including Arabic text
• Obtain the import permits, release approvals and certificates needed for each shipment
• Keep an up-to-date database of each product's registration status and expiry date
• Follow new regulatory circulars and changes and brief management on their impact on products

Working conditions

• Frequent visits to regulatory and government offices

Requirements

• Bachelor's degree in pharmacy or pharmaceutical sciences
• 3 to 6 years of experience in drug registration and regulatory affairs

The years of experience follow the level you choose when posting.

Skills

• Drug registration
• Registration dossiers (CTD)
• Pharmaceutical regulations
• Label and leaflet review
• Pharmacovigilance
• Document control
• Accuracy and organization

Preferred

• Experience registering medical devices or cosmetics
• Experience with a local agent for foreign pharmaceutical companies
• Good English for technical dossiers and correspondence