Regulatory Affairs Officer

In the context of a new project for one of our top Pharma clients, we’re looking for a talented consultant to lead the following missions, and much more!

Responsibilities:

• Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
• Gain regulatory authority approval
• Provide ongoing regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
• Provide regulatory support to clients and associate companies
• Liaise with external regulatory authorities as required
• Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labeling
• Review tasks for, support, and mentor Regulatory Affairs Associates

• Degree in Life Science/ Pharmacy degree would be a plus
• First experience in Regulatory Affairs in the Pharmaceutical industry
• Knowledge of Africa and/or MENA regulations for pharmaceuticals (NCE, Biologicals, and Biotech)
• Excellent communication skills in English, French, and Arabic
• Excellent attention to detail
• Ability to work well within a multicultural team
• Good time management skills