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.
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
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Interested candidates must send their application letters, updated CV (including three referees), copies of academic certificates and daytime telephone contact to the undersigned through email below by 15th Dec, 2023.
rnyatangi@ke.aspenpharma.com
cpatel@ke.aspenpharma.com
mmathenge@ke.aspenpharma.com
Apply via :
rnyatangi@ke.aspenpharma.com
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