REGULATORY OFFICER – EXEMPTIONS & RENEWALS (x2 positions)- Botswana Medicines Regulatory Authority (BOMRA) 611 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.

 

REGULATORY OFFICER – EXEMPTIONS & RENEWALS (X2)

Reporting directly to Manager Complementary Medicines & Cosmetics Main Purpose of Job

Assessing information in dossiers submitted by applicants seeking exemptions from going through the normal marketing authorisation or post registration variations against relevant

 

applicable legal and scientific regulatory standards to ensure speedy processing of authorizations so that medicines, medical products and cosmetics of acceptable quality are accessible in the market.

Main Duties

• Process applications for exemptions from going through the normal registration process for new medicines, medical products and cosmetics or exemptions to the normal variation process of existing authorizations by assessing and evaluating dossiers submitted against regulatory quality, safety and efficacy standards to protect the health and wellbeing of the public and of animals.
• Assist manufacturers and distributors with scientific and legal information, guidelines, and clarifications on the compliance requirements for market authorization in response to enquiries or proactively as part of educational interventions initiated by the Authority to promote high levels of compliance.
• Conducting scientific evaluation of data in dossiers or additional information provided by applicants for exemptions in response to formal requests for further information to determine accuracy and adequacy for consideration for marketing authorization.
• Assist internal audit activities by providing required information to in accordance with the audit policy, procedures and plans

of the Authority to ensure a work-class internal quality management system.

• Write product exemptions evaluation or post assessment reports in accordance with BOMRA guidelines for review by peers and submission to the Registration Committee of the Authority to support effective market authorization decision making
• Write letters communicating the decision of the Authority to applicants in accordance with BOMRA guidelines to ensure understanding and customer satisfaction
• Maintain data bases of applicants and local representatives of applicants and of market authorization decisions in accordance with BOMRA guidelines

to ensure easy and timely access for reference or any other relevant subsequent intervention.

• Seek to achieve personal and team performance targets in accordance with performance plans and business plans to ensure high level of productivity and customer satisfaction.
• Contribute to the development and

 

maintenance of quality management documentation to ensure an efficient and effective system of capturing, storing and sharing information with relevant stakeholders.

• Maintain continuous professional development by engaging in self-study and membership of professional institutes to ensure personal professional growth and increased value to BOMRA.

Qualifications:

Degree in Pharmacy or related field Post graduate training in regulatory affairs

Experience and skills:

Successful completion of the postgraduation government internship Medicines, health products and cosmetics regulatory affairs

• Technical Report Writing
• Information technology