REGULATORY PHARMACIST -Medirex Pharmaceuticals

VACANCY 
 

Medirex Pharmaceuticals are looking for a Regulatory Pharmacist who is specialized in the assessment of medicines efficacy, safety, and quality. Our ideal candidate has thorough understanding of pharmaceutical distribution administration; moreover, you are passionate about pharmaceutical operations and medicine regulation in Africa.

Job Summary

* Overseeing and manage the operations of a pharmaceutical distribution organisation.
* Oversee the budget and expenditure of the budget.
* Coordinating regulatory inspections.
* Ensuring that the company’s products comply with the regulations of the Botswana Medicines Regulatory Authority (BOMRA).
* Assessing of major and minor variations to registered medicines.
* Receiving, reviewing and filing dossiers for registration of new products and variations.
* Consulting advice on and coordinating the approval and registration of pharmaceuticals and complementary medicines.
* Assessing the quality and safety of small molecule medicines.
* Assessing the bioequivalence studies for generic medicine applications.
* Consulting on strategic policies to senior management throughout new product development.
* Facilitate in-house trainings on quality and efficacy assessment of medicine dossiers to junior level officers.
* Comply with all applicable legal rules, regulations and procedures.

Minimum Education, Training and Experience Requirements

* Bachelor (Hons) Degree of Pharmacy.
* Registered with Botswana Health Professional Council (BHPC).
* At least two (3) years regulatory experience.
* Should have work experience in a Medicines Regulatory Authority.