East
African Community
Applications are invited from suitably qualified citizens of East African
Community Partner State of Kenya for the following EAC regional health sector
project staff position under the East African Community Medicines Regulatory
Harmonization Initiative (EACMRHI) Project tenable in the Kenya National
Medicines Regulatory Authority
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.