The Role
Participates in the implementation and development of the Regulatory Strategy. | | Develops and updates Standard Operating Procedures for registration of medicine with MCAZ in line with local and international legislature. | | Develops and updates the budget for product registrations consolidating inputs, requirements, and allied products from the relevant units. | | Assembles a regulatory file/dossier by coordinating the acquisition for all applicable data, assessed data and drafts. | | Verifies if collected data complies with current local and international legislature format. | | Analyses and verifies file contents. | | Conducts accurate assessments to anticipate questions and critical issues from the regulator. | | Submits the regulatory file to MCAZ. | | Updates clinical and pre-clinical data. | | Responds to questions from regulatory authorities. | | Conducts Regulatory monitoring of approved products. | | Monitors commitments/obligations in line with regulatory requirements. | | Assists and supports in house teams with compliance. | | Prepares Weekly and monthly reports.
The Person
Degree in Science (Pharmacy, Pharmacology, Biochemistry) or related discipline. | | Certificate in Dossier assessments. | | At least 2 years experience. | | Master`s Degree in related discipline is an added advantage. | | Excellent verbal and written communication skills and an ability to prepare accurate reports. | | Ability to plan and organise in line with job requirements. | | Ability to analyse and solve work related problems while achieving the right outcome simultaneously. | | Ability to interact, negotiate (where applicable) and achieve targets.
If you are interested and you meet the stipulated requirements, please attach your letter of motivation and CV . Due date (Monday 24 July 2023)