Director, Product Evaluation & Registration
Overview of role
To oversee the management of human, financial and other resources allocated to the department to ensure efficient and effective regulation and control of human and veterinary medicines, medical devices, complementary medicines and cosmetics for protection and promotion of human and veterinary public health.
- To advise the CEO on matters pertaining to product evaluation and registration
- Ensure that drug applications are assessed according to approved guidelines and regulations for registration
- Actively participate in and coordinate the development of regulations and procedures of drug registration.
- Manage the development and maintenance of computerised software and database for registered drugs.
- To ensure all human and veterinary medicines, medicated feeds, medical devices, vaccines and biological products, complementary medicines and cosmetic products are correctly evaluated for quality, safety and efficacy.
- Ensure timely update of the registers with approved variations, new products, suspensions and deletions
- Works closely with the necessary department heads to implement quality management systems in the department
- Manage, assess and evaluate variation applications for registered products (human and veterinary drugs, complementary medicines and related products)
- Manage, motivate and coach employees in the department and manage their performance through regular communication and timely feedback annual performance appraisal and making provision for appropriate training and development options
- Prepare, implement and monitor departmental budget and annual work plans to achieve the organisational strategic objectives.
- To foster cooperation with regional and international bodies on matters pertaining to the department.
- To ensure effective management of the Post Marketing Surveillance and Control of Clinical Trials unit in the MRA’s formative stage.
- Holder of MSc or its equivalent in Pharmacy, Human Medicine, Veterinary Medicine or related field from recognized institution
- Ability to work independently, good interpersonal and communication skills; good working knowledge of ICT Applications.
- High degree of integrity and probity; Excellent organizational skills; Strong ability to follow detailed processes and procedures; Precision in execution of work with attention to detail; Initiative, diplomacy and good judgement; Good written and oral communication skills; Good interpersonal skills and team spirit; Tact and discretion in the handling of confidential files and information
- At least ten years’ experience in current regulatory affairs and six years in senior managerial position in a reputable organization