Description de l'annonce:

We are looking for a Regulatory Affairs Assistant (RAA) to join our Regulatory Affairs team.

MAIN RESPONSIBILITIES

• To contribute to the production of client administrative documents to be included in regulatory submissions
• Compile regulatory dossiers in accordance with national and international requirements
• To document and track regulatory submissions and regulatory authority approval inside document management systems
• Provide regulatory support to clients and associate companies
• Liaise with external regulatory authorities as required
• Provide review of packaging texts
• To provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check)
• Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services
• Assist in the preparation or update of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)

Education/ Experience

• Bachelor’s degree in life Science/ Pharmacy related field
• 1-2 years of experience in regulatory affairs in Pharmaceutical Industry
• Knowledge of Africa and/or MENA regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
• Knowledge of EDMS

Skills

• Fluent in English/ French (written &spoken)
• Excellent attention to detail
• Ability to work well within a team
• Good time management skills
• Ability to work to tight deadlines
• Process oriented
• Excellent communication skills