DOSSIER ASSESSOR– VETERINARY MEDICINES – March 2023

The Botswana Medicines Regulatory Authority (BoMRA) is a body that was established through the Medicines and Related Substances Act of 2013, to regulate the supply chain of Human and Authority is looking for professionals to join their growing teams.

DOSSIER ASSESSOR– VETERINARY MEDICINES

JOB PURPOSE:

Reporting directly to the Manager Veterinary Medicines. The purpose of this role 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.

RESPONSIBILITIES:

• To support and advise the management on all matters pertaining to veterinary medicinal products evaluation and registration.
• To provide support to the management on the development and implementation of the Unit budget.
• To support the Finance department by checking and confirming fees quoted vs. SRFs submitted.
• To review screening applications, new applications for registration, responses and additional information, variations, exemptions, and renewals to determine the quality, safety, and efficacy of veterinary medicinal products.
• To prepare and present technical assessment reports on applications for registration, postregistration variations and renewals to the peer review, registration committee and Zazibona meetings.
• To communicate timely, the assessment outcomes and Registration Committee decisions to the applicants e.g., list of queries, approvals, or rejections.
• To support the maintenance of up-to-date medicines registers and application databases.
• To plan, prepare, facilitate and/or attend in-house technical and administrative training.
• To serve as a Focal Point for collaborative work within SADC Regulatory Harmonisation- Zazibona, and other international technical collaboration platforms (WHO CRP, WOAH, ICH, VICH, TWG) and provide updates when required.
• To respond to customer inquiries in an approved format / platform.
• To prepare and present material for stakeholder engagements and regional or international meetings on behalf of the Authority.
• To develop and/or review processes, standards or guidelines and associated templates for registration of human, veterinary or complementary medicines
• To lead the Quality, Risk and Audit activities for the department
• To collaborate with other Departments within BoMRA on matters pertaining to medical products registration
• To perform any other relevant tasks or duties as required by the Authority.

QUALIFICATIONS:

You will need to possess a Degree in Veterinary Science/Animal Health/Pharmacy with a minimum of three (3) years’ experience working in pharmaceutical sectors, Government, national or international NGOs

Competencies:

Understanding of ISO 9001, 17020 or 17025, and VMP regulatory framework in Botswana.

If you believe that you have the above capabilities, meet the minimum requirements and would like to grow with BOMRA, kindly send your application, latest CV and certified copies of certificates and two(2) current referee’s details to: recruitment@bomra.co.bw

Closing Date for Submission: 04 April 2023. Only shortlisted candidates will be contacted within a period of 30 calendar days