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Regulatory Affairs Officer

Description

As a result of a new project we are looking for a Regulatory Affairs Officer to contribute to the regulatory activities performed on the RA Platform/the Hub:

Responsibilities

• Compile, or supervise the compilation of regulatory dossiers in accordance with national/ international requirements.
• Reviewing artworks
• Gain regulatory authority approval
• Liaise with external regulatory authorities as required.
• 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 and metrics for regulatory services supplied by the platform/hub
• To contribute to the production of client administrative documents and reports to be included in regulatory submissions
• 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
• 3 years in a regulatory affairs department

Skills

• Knowledge of Africa and/or MENA regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products
• Knowledge of EDMS, MS Word, MS Excel
• Experience with promotional materials would be appreciated
• 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
• Excellent communication skills