EAC National Medicines Regulation Officer Job Vacancy in Zanzibar

Duty Station: Zanzibar, United Republic of Tanzania.

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 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;

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 subnational
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 subnational
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. Training in WHO-Prequalification and Medicines Regulation Affairs
iv. Work experience of five (5) years of which two (2) should be in medicines
regulation, policy, guidelines and standards development.
v. 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 United Republic of
Tanzania (Zanzibar)

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 and Social Welfare
United Republic of Tanzania (Zanzibar),
P O Box 236,
Zanzibar, Tanzania.
Tel: +255 77 410954

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.

Female candidates are encouraged to apply.

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 Wednesday, 29th February 2012.