Regulatory Officer: Inspections (x2 Positions) – Botswana Medicines Regulatory Authority

Job Description

JOB PURPOSE

To carry out inspections of any premises or activities which deal
in research, manufacturing, marketing, dispensing,
distribution, storage or handling, import or export of medical products, cosmetics and related substances for compliance with the Medicines and Related Substances Act (MRSA) and regulations.

JOB RESPONSIBILITIES

1. To inspect pharmaceutical manufacturing facilities within the country and abroad for compliance with Good Manufacturing Practices and report on findings with recommendations for certification.
2. To inspect local pharmaceutical premises where medicines and related substances are stored, used, handled, dispensed, or sold, and any vehicle,
trans shipment, or receptacle in which medicines are transported for compliance against relevant guidelines and report on findings with recommendations.
3. To perform consignment verification checks to facilitate the importation and exportation of medicines medical devices and cosmetics, and related substances, for compliance with set guidelines.
4. To contribute to the development and documentation of processes, procedures and guidelines that facilitate the implementation of the inspection and licensing mandate.
5. To periodically prepare reports for the assigned activities of the Inspections and licensing department.
6. To issue importation and exportation authorization for medicines and related substances in compliance with MRSA requirements.
7. To perform verification checks on all permits issued for the importation and exportation of medicines and related substances in compliance with MRSA requirements.
8. To follow up on complaints/reports related to inspection and licensing activities as assigned.
9. To provide information and intelligence to enforcement officers for further investigation.
10. To perform assigned stakeholders’ engagement activities to facilitate compliance to requirements set in accordance with MRSA and regulations thereto.
11. To support enforcement function on the activities that may require the involvement of the inspection and licensing unit contribution.
12. To provide customer service in line with established service standards
13. Prepare licenses for complying premises following an inspection.
14. To support Post Marketing Surveillance activities by implementing the sampling frame and following up on recalls.
15. Implement a collaborative agreement between BoMRA and identified stakeholders to facilitate the mandate of inspection and licensing.
16. To undertake any other responsibilities, tasks or activities as may be assigned from time to time in line with BoMRA mandate.
Academic

Qualifications:

The ideal candidate should hold a Bachelor’s degree in Pharmacy, Veterinary, Medicine, Biomedical sciences or related health Sciences. A qualification in Law from a recognized Institution will be an added advantage.

Work experience:

At least three years of working experience in a reputable pharmaceutical establishment; Previous experience in regulatory affairs is an advantage

Essential 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:

High level of Integrity; Keen attention to detail; excellent communication and interpersonal skills; ability to write clear and comprehensive technical reports; teamwork.