DOSSIER ASSESSOR- HUMAN MEDICINES (X1)
To ensure that human medicines that are authorized to be in the market comply with legal and regulatory requirements in Botswana with respect to quality, safety, and efficacy.
1. To provide support to the Manager, to deliver evaluation services for human, veterinary or complementary medicines at the MRA.
2. To establish and/or review the processes, and standards or guidelines for registration of human, veterinary or complementary medicines
3. To timely conduct administrative or technical assessments of applications for pre-marketing authorization, post-registration variations and renewals to determine the quality, safety and efficacy of medicines and other medicinal products.
4. Preparation of technical assessment reports on the acceptability of data submitted in the applications for registration, post-registration variations and renewals.
5. Work closely with the respective manager and Head of the Evaluation and Registration department to ensure that all approved products in the market comply with legal and regulatory requirements in Botswana with respect to quality, safety, and efficacy.
6. Preparation and/or review of technical documents (reports, agenda and minutes) for submission to the MRA’s Registration Committee for regulatory decision.
7. To process applications for exemption from registration of medical products
8. Timely communication of the assessment outcomes and/or Registration Committee decisions to the applicants.
9. Support the maintenance of an up-to-date medicines registers and application databases.
10. Assist the Manager and/or Head Product Evaluation and Registration to document and maintain EQMs documentation: updated guidance document, standard operating procedures (SOPs), templates, reference materials, and tools.
11. To efficiently support the management of all external contracts, and to ensure that all the Company’s expenditure is correctly authorised and accounted for.
12. To engage and educate stakeholders on requirements and process for registration of medical products
13. Perform any other tasks or duties required by the Evaluation and Registration department of MRA.
• Academic Qualifications: Holder of a Degree in pharmacy, veterinary science or any other relevant qualification; proficiency in written and spoken English
• Work experience: 3 years’ working experience in pharmaceutical sectors, Government, national or international NGOs.
• Essential skills: Ability to plan and work independently, interpersonal skills; presentation skills; 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.
Competencies: Ability to write clear and comprehensive technical reports; teamwork.
The Authority offers competitive remuneration packages commensurate with job specifications.
If you have the above capabilities, meet the minimum requirements and believe you can grow with BOMRA, kindly send your applications, latest CV, and certified copies of certificates and 2 current referees’ details to firstname.lastname@example.org
Closing date: 04 January 2023
Only shortlisted candidates will be contacted.