DOSSIER ASSESSMENT SPECIALIST – VETERINARY MEDICINES (x3 positions) – Botswana Medicines Regulatory Authority (BoMRA) 608 views

The Botswana Medicines Regulatory Authority (BoMRA) is an organisation set up under the Medicines and Related Substances Act (MRSA) of 2013 and was established by the Botswana Government to regulate the supply chain of medicines and related substances, cosmetics and medical devices in order to ensure their quality, safety and efficacy. The Authority is looking for Talent to occupy the following position and become a part of a vibrant High performing team.

 

DOSSIER ASSESSMENT SPECIALIST – VETERINARY MEDICINES (X3)

Reporting directly to the Manager Veterinary Medicines Main Purpose of Job

Your main responsibility is to ensure that Veterinary medicines that are authorized to be in the market comply with legal and regulatory requirements in Botswana with respect to quality, safety, and efficacy.

Main Duties:

Your duties include,

• administrative and technical review of the quality, non-clinical and clinical data submitted in support of applications for registration and post approval variations of medicines, preparation of technical reports for submission to the relevant committee for regulatory decisions and, ensure that the necessary guidelines, standard operation procedures and reference materials are in place for medicines registration.

Qualifications

You will need to possess a Degree in Pharmacy/Veterinary Science/

Human Medicines with a minimum of three (3) years’ experience working in pharmaceutical sectors, Government, national or international NGOs. Competencies

The key competencies for the role include proficiency in written and spoken English; an ability to plan and work independently; interpersonal skills; presentation skills; attention to detail; good knowledge of pharmaceutical regulatory issues; knowledge of aspects of Botswana and regional medicines policies, and legislative system governing pharmaceuticals; and good knowledge of ICT applications as well as an ability to write clear and comprehensive technical reports; teamwork.