Kenya National Medicines Regulation Officer
(One Post) - REF: EAC/HR/HEALTH/2011-2012/006
Grade: Consolidated Salary equivalent to EAC P1 Staff Grade
Reports to: Head, Medicines Registration, Pharmacy and Poisons
Duration of Contract: Initially Three (3) Years
Duty Station: Nairobi, Kenya
Main Purpose of the Job:
In liaison with the Senior Health Officer (Medicines Regulation) at the EAC Secretariat headquarters in Arusha, Tanzania as well as the Head and other relevant technical officers of the National Medicines Regulatory Authority (NMRAs) in the respective East African Community Partner States, coordinate and facilitate the harmonization and implementation of various EAC regional medicines registration and regulation policies, legislation, strategies, guidelines, standards, legal and regulatory frameworks in order to enhance the affordability, quality, efficacy and safety of both human and veterinary medicines and related pharmaceutical products and supplies that are manufactured, imported and/or traded within the East African Community region.
Duties and Responsibilities:
- Coordinate and facilitate the harmonization and implementation of various EAC regional medicines registration and regulation policies, legislation, strategies, guidelines, standards, legal and regulatory frameworks at national and sub-national levels in the respective East African Community Partner States in order to enhance the affordability, quality, efficacy and safety of both human and veterinary medicines and related pharmaceutical products and supplies that are manufactured, imported and/or traded within the East African Community region.
- Coordinate the development and implementation of a Common Technical Document (CTD) for registration of medicines at national and sub-national levels in the respective EAC Partner States in accordance with the existing World Health Organization (WHO) Regulatory Documentation Package, International Conference on Harmonization (ICH) Global Cooperation Group (ICH-GCG) and other relevant international guidelines and standards;
- Support the development and implementation of a common EAC regional Information Management System (IMS) for medicines registration linked to each of the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs);
- Provide technical support in the implementation of Quality Management System (QMS) in the respective National Medicines Regulatory Authorities (NMRAs) in each of the EAC Partner States using Risk-Based Approaches (RBAs) and processes in accordance with priority public health needs with regard to enhancing access to safe, effective, quality and affordable essential human and veterinary medicines and related pharmaceutical products and supplies that are manufactured, imported and/or traded within the EAC Partner States.
- Develop and implement capacity building programmes at both national levels and sub-national levels in support of the harmonization and strengthening of medicines registration and regulation in the EAC Partner States.
- Support the creation and operationalization of a web-based platform for information sharing on harmonized medicines registration and regulation systems and procedures among key stakeholders at both national and subnational levels in the EAC Partner States.
- Support the development and implementation of a regional policy as well as a legal and regulatory framework for mutual recognition of the registration and regulation of both human and veterinary medicines and pharmaceutical products and supplies based on Chapter 21, Article 118 of the Treaty on the Establishment of the East African Community.
- Support the establishment of the decentralized East African Community Medicines and Food Safety Commission (EACMFSC) which will be an autonomous institution of the Community responsible for regional coordination of the regulation and safety of all human and animal medicines, foods, feeds as well as human and veterinary pharmaceutical products, supplies, cosmetics, devices, vaccines, vitamins, sera and others biological products that are manufactured, imported and/or traded within the EAC region.
- Establish a national mechanism for using regulatory information from the respective EAC Partner States’ National Medicines Regulatory Authorities (NMRAs) (assessments/decisions, etc) and for making information available to the general public and other multisectoral stakeholders and partners (legislation, guidelines and lists of registered products, including rejected applications, etc.)
- Support the implementation of the EAC regional policies, guidelines, standards, procedures as well as legal and regulatory framework for joint evaluations of dossiers and inspections of medicine manufacturing sites and to ensure that these assessments are integrated into national and subnational decision-making processes as applicable.
- Build national capacity to implement medicines registration and regulation harmonization (including developing a capacity building programme for technical, financial and management staff and project management inc. monitoring and evaluation) including contributing to the establishment of the decentralised East African Community Medicines and Food Safety Commission (EACMFSC);
- Develop and implement a national advocacy and communication strategy to sensitize key stakeholders at national and sub-national levels and to build ongoing multisectoral stakeholder commitment (including political and local community commitment for developing and implementing policy and legislative amendments on medicines registration and regulation)
- Facilitate national medicines registration and regulation policy and legislative review in the respective East African Community Partner States in order to incorporate the changes that will occur as a result of the harmonization of medicines registration and regulation among the Countries.
- Coordinate and facilitate operational research, monitoring and evaluation and reporting of various national and sub-national medicines registration and regulation projects, programmes and initiatives in liaison with the relevant technical counterparts in the National Medicines Regulatory Authorities (NMRAs) of the respective EAC Partner States
Qualification and Experience:
- A Bachelors Degree in Pharmacy from a recognized University;
- A Masters Degree or other relevant post-graduate qualification in Pharmaceutical, Public Health or other Health-Related Sciences is an added advantage
- Work experience of five (5) years of which two (2) should be in medicines regulation, policy, guidelines and standards development.
- Demonstrated regional and international training experience in the harmonization medicines registration and regulation will be an added advantage.
Skills and Competencies:
Analytical skills, interpersonal communication, report writing, leadership, teamwork, supervisory and planning skills.
Candidates eligible for the position: Citizens from the Republic of Kenya
How to Apply
Interested candidates should submit their applications quoting the reference number of the position applied for by registered mail or courier service and dispatched directly together with the full curriculum vitae, copies of both academic and professional certificates and testimonials, names and addresses of three referees, day time telephone /cell phone numbers to:
Permanent Secretary
Ministry of Medical Services,
Afya House (6th Floor), Cathedral Road,
P O Box 30016-00100,
Nairobi Kenya.
Tel: +254- (0) 20-2717077
Fax: +254- (0) 20-2713234
Terms and Condition of Service
This EAC Country level health sector project staff position has an initial three year contract that may be renewed subject to satisfactory performance and availability of donor funds.
Closing Date: All applications together with copies of relevant attachments should be received at the respective EAC Partner States’ National Ministries responsible for Health no later than Friday, 15th June 2012.
Kenya National Medicines Regulation Officer
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