Job Title:RWANDA NATIONAL MEDICINES REGULATION OFFICER
(ONE POST) - REF: EAC/HR/HEALTH/2011-2012/009
Grade: Consolidated Salary equivalent to EAC P1 Staff Grade
Reports to: Head, Medicines Registration, Rwanda National
Medicines Regulatory Authority (NMRA),
Duration of Contract: Initially Three (3) Years
Duty Station: Kigali, Rwanda.
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:
1. 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.
2. Coordinate the development and implementation of a Common Technical
Document (CTD) for registration of medicines at national and subnational
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;
3. 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);
4. 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.
5. 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.
6. 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
sub-national levels in the EAC Partner States.
7. 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.
8. 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.
9. 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.)
10. 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 sub-national decision-making processes as applicable.
11. 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);
12. 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)
13. 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.
14. 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:
i. A Bachelors Degree in Pharmacy from a recognized University;
ii. A Masters Degree or other relevant post-graduate qualification in
Pharmaceutical, Public Health or other Health-Related Sciences is an
added advantage
iii. Work experience of five (5) years of which two (2) should be in medicines
regulation, policy, guidelines and standards development.
iv. 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 Rwanda
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
dispatch 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 Health,
Republic of Rwanda
P O Box 84,
Kigali, Rwanda.
Tel:+250 577458
TERMS AND CONDITION OF SERVICE
This EAC Country level health sector project staff position has an initial threeyear
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.
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