Regulatory Affairs duties

• To initiate, monitor and implement the cycle of product registration with various regulatory authorities ie New registrations, request for additional information, variations/amendment, renewals, retentions etc.
• Ensuring compliance with regulations set by the Regulatory Authorities.
• Coordinate timely response to Regulatory Authorities’ queries in liaison with the relevant departments.
• Liaising, negotiating and maintaining correspondence with regulatory authorities.
• Maintaining an up-to-date register of status of product registrations in the different countries.
• Timely submission of monthly / quarterly / review reports for Regulatory affairs activities.
• Implementation and coordination of Regulatory Affairs Projects.
• Participating in external audits/inspections by various approving authorities.
• Review and approval of product artworks.
• Advise and participate in any quality management system reviews that may be necessary from regulatory guidelines.
• Coordinate product registration / submission of dossiers for affiliate and partnering companies to various territories within the Sub-Saharan Africa (SSA) & French West Africa (FWA) regions.
• Provide Regulatory & Pharmacovigilance Intelligence in various countries within the SSA, FWA, EA & AWA regions, to Aspen Group and internally as applicable.
• Any other duties as allocated by Management.

Requirements

Desired Profile

• Education: Bachelor of Pharmacy (Registered with pharmacy and Poisons board, Kenya)
• Experience: +2 years
• Good knowledge of Microsoft office and databases

Reporting Line

• To Manager-Pharmacovigilance and Regulatory Affairs