SENIOR HEALTH OFFICER (MEDICINES REGULATION)
Applications are invited from suitably qualified citizens of the East African Community Partner States (Burundi, Kenya; Tanzania; Uganda and Rwanda) for the following EAC regional health sector project staff positions under the East African Community Medicines Regulatory Harmonization Initiative (EACMRHI) tenable at the EAC Secretariat headquarters in Arusha, Tanzania.
SENIOR HEALTH OFFICER (MEDICINES REGULATION)
REF: EAC/HR/HEALTH/2011-2012/001
Grade: Professional Staff Category (P2 Equivalent)
Reports to: EAC Senior Health Officer (Medicines and Food
Safety);
Organ/Institution: EAC Secretariat
Duration of Contract: Initially Three (3) Years
Station: EAC Secretariat, Arusha - Tanzania
Main Purpose of the Job:
To coordinate and support the implementation of EAC regional health sector policies, legislation, strategies, plans, projects, programmes and initiatives on medicines regulation in the EAC Partner States in liaison with the National Medicines Regulatory Authorities (NMRAs) in order to enhance 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 East African Community region.
.
Duties and Responsibilities:
1. Coordinate the development and implementation of a Common Technical Document (CTD) for registration of medicines in the 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;
2. Coordinate the development and implementation of a common EAC
regional Information Management System (IMS) for medicines
Closing Date: Friday, 15th June 2012 1
registration linked to each of the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs);
3. Provide technical support in the implementation of Quality Management System (QMS) in each of the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs) 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 East African Community region.
4. Develop and implement capacity building programmes at both regional and national levels to support the harmonization and strengthening of medicines registration and regulation in the EAC Partner States
5. Coordinate 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 regional level
6. Coordinate 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.
7. Facilitate the establishment of the decentralized East African Community Medicines and Food Safety Commission (EACMFS) 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.
8. Establish an EAC regional mechanism for using regulatory information from the 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.)
9. Establish EAC regional policies, guidelines, standards, Standard Operating Procedures (SOPs) as well as legal and regulatory frameworks for joint evaluations of dossiers and inspections of various medicine and pharmaceutical manufacturing sites and to ensure that these assessments are integrated into national and regional decision-making processes as applicable.
10. Build regional and 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
Closing Date: Friday, 15th June 2012 2
contributing to the establishment of the decentralized East African Community Medicines and Food Safety Commission (EACMFSC);
11. Develop and implement an EAC regional advocacy and communication strategy to sensitize key stakeholders at regional and 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)
12. Facilitate regional medicines registration and regulation policy and legislative review among the 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.
13. Coordinate and facilitate operational research, monitoring and evaluation and reporting of various EAC regional medicines registration and regulation projects, programmes and initiatives in liaison with the relevant technical counterparts in the National Medicines Regulatory Authorities (NMRAs) of the 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 preferable
iii. Work experience of five (5) years of which two (2) should be in medicines regulation, policy, guidelines and standards development.
iv. Demonstrated national, 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.
TERMS AND CONDITION OF SERVICE
This EAC regional 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.
HOW TO APPLY
Interested candidates should submit their applications quoting the reference number of the position applied for by registered mail, courier service, e-mail and dispatch directly together with the full curriculum vitae, copies of both
Closing Date: Friday, 15th June 2012 3
academic and professional certificates and testimonials, names and addresses of three referees, day time telephone /cell phone numbers to:
The Secretary General
East African Community
P.O. Box 1096,
Arusha, Tanzania
Fax: +255-27-250425354
Email: eac@eachq.org
Closing Date: All applications together with copies of relevant attachments should be received at the EAC Secretariat headquarters in Arusha, Tanzania no later than Friday, 15th June 2012.
SENIOR HEALTH OFFICER (MEDICINES REGULATION)
REF: EAC/HR/HEALTH/2011-2012/001
Grade: Professional Staff Category (P2 Equivalent)
Reports to: EAC Senior Health Officer (Medicines and Food
Safety);
Organ/Institution: EAC Secretariat
Duration of Contract: Initially Three (3) Years
Station: EAC Secretariat, Arusha - Tanzania
Main Purpose of the Job:
To coordinate and support the implementation of EAC regional health sector policies, legislation, strategies, plans, projects, programmes and initiatives on medicines regulation in the EAC Partner States in liaison with the National Medicines Regulatory Authorities (NMRAs) in order to enhance 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 East African Community region.
.
Duties and Responsibilities:
1. Coordinate the development and implementation of a Common Technical Document (CTD) for registration of medicines in the 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;
2. Coordinate the development and implementation of a common EAC
regional Information Management System (IMS) for medicines
Closing Date: Friday, 15th June 2012 1
registration linked to each of the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs);
3. Provide technical support in the implementation of Quality Management System (QMS) in each of the EAC Partner States’ National Medicines Regulatory Authorities (NMRAs) 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 East African Community region.
4. Develop and implement capacity building programmes at both regional and national levels to support the harmonization and strengthening of medicines registration and regulation in the EAC Partner States
5. Coordinate 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 regional level
6. Coordinate 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.
7. Facilitate the establishment of the decentralized East African Community Medicines and Food Safety Commission (EACMFS) 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.
8. Establish an EAC regional mechanism for using regulatory information from the 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.)
9. Establish EAC regional policies, guidelines, standards, Standard Operating Procedures (SOPs) as well as legal and regulatory frameworks for joint evaluations of dossiers and inspections of various medicine and pharmaceutical manufacturing sites and to ensure that these assessments are integrated into national and regional decision-making processes as applicable.
10. Build regional and 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
Closing Date: Friday, 15th June 2012 2
contributing to the establishment of the decentralized East African Community Medicines and Food Safety Commission (EACMFSC);
11. Develop and implement an EAC regional advocacy and communication strategy to sensitize key stakeholders at regional and 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)
12. Facilitate regional medicines registration and regulation policy and legislative review among the 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.
13. Coordinate and facilitate operational research, monitoring and evaluation and reporting of various EAC regional medicines registration and regulation projects, programmes and initiatives in liaison with the relevant technical counterparts in the National Medicines Regulatory Authorities (NMRAs) of the 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 preferable
iii. Work experience of five (5) years of which two (2) should be in medicines regulation, policy, guidelines and standards development.
iv. Demonstrated national, 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.
TERMS AND CONDITION OF SERVICE
This EAC regional 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.
HOW TO APPLY
Interested candidates should submit their applications quoting the reference number of the position applied for by registered mail, courier service, e-mail and dispatch directly together with the full curriculum vitae, copies of both
Closing Date: Friday, 15th June 2012 3
academic and professional certificates and testimonials, names and addresses of three referees, day time telephone /cell phone numbers to:
The Secretary General
East African Community
P.O. Box 1096,
Arusha, Tanzania
Fax: +255-27-250425354
Email: eac@eachq.org
Closing Date: All applications together with copies of relevant attachments should be received at the EAC Secretariat headquarters in Arusha, Tanzania no later than Friday, 15th June 2012.
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