Beta Healthcare international ltd, a member of the Aspen Group of Companies, is a leading pharmaceutical manufacturer and distribution company in sub-Saharan Africa, based in Nairobi, Kenya.

We are seeking to recruit qualified individuals for the above position

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.

Regulatory Affairs duties

1. 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.
2. Ensuring compliance with regulations set by the Regulatory Authorities.
3. Coordinate timely response to Regulatory Authorities’ queries in liaison with the relevant departments.
4. Liaising, negotiating and maintaining correspondence with regulatory authorities.
5. Maintaining an up-to-date register of status of product registrations in the different countries.
6. Timely submission of monthly / quarterly / review reports for Regulatory affairs activities.
7.  Implementation and coordination of Regulatory Affairs Projects.
8. Participating in external audits/inspections by various approving authorities.
9. Review and approval of product artworks.
10. Advise and participate in any quality management system reviews that may be necessary from regulatory guidelines.
11. 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.
12. Provide Regulatory & Pharmacovigilance Intelligence in various countries within the SSA, FWA, EA & AWA regions, to Aspen Group and internally as applicable.
13. Any other duties as allocated by Management.

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.

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