Senior Regulatory Affairs Specialist

Job Description

<strong>Job Purpose: </strong><p><br></p><ul><li>Labeling and Pack management across NEMAG and regulatory activities across Maghreb.</li></ul><p><br></p><strong> Key Areas of Responsibility:</strong><p><br></p><ul><li>Responsible for pack management in NEMAG including cluster specific and std. packs as per the internal process and according to the local regulations for imported and locally manufactured products.</li><li>Maintenance of the existing specific packs (all components artworks: Leaflet, Carton, blister…) according to variations submitted and impacting the supply chain (labelling /artworks management) including Algeria local manufacturing products</li><li>Preparation of reference document according to local HA requirement and implementation the change</li><li>Responsible of regulatory license maintenance activities across Maghreb cluster</li></ul><p><br></p><strong>Minimum Criteria and Competencies:</strong><p><br></p><ul><li>Bachelor degree in Pharmacy</li><li>Working as regulatory affairs in pharmaceutical company for minimum of 3 years</li><li>Pack and label experience</li><li>Preferred to have regulatory experience in Morocco</li><li>Good command of English</li><li>Communication skills</li><li>Cross-functional collaboration</li></ul>