Summary
Date Posted: Thursday, October 10 2024, Base Salary: Not Disclosed

JOB DETAILS:
Background
The Zambia Medicines Regulatory Authority (ZAMRA) is a statutory body established under the Medicines and Allied Substances Act (No. 3) of 2013, responsible for the regulation of medicine and allied Substances in Zambia. The Authority invites applications from suitably qualified Zambian citizens who are ambitious, innovative, energetic and performance-driven to apply for various positions as follows:

1.0 ASSISTANT DIRECTOR – LICENSING, SURVEILLANCE & ENFORCEMENT (1)
Purpose
To supervise effectively inspections and licensing of pharmaceutical premises and post marketing surveillance in order to achieve compliance to statutory regulations.

Person Specifications and Qualifications
a) Full Form V/ Grade 12 School Certificate (including English and Mathematics);
b) Bachelor of Pharmacy Degree/ Bachelor of Veterinary Medicine /or any related Science;
c) Membership to relevant professional bodies; and
d) 8 years experience of which 3 years at managerial level.

Required Skills and Attributes
a) Proficiency in computer skills;
b) Good analytical skills;
c) Good planning and organization skills;
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Good communication skills;
g) Must be conversant with Microsoft packages; and
h) Good report writing skills.

Duties and Responsibilities
a) Co-ordinate effectively, licensing of pharmaceutical premises and facilities in order to safeguard the integrity of medicines and allied substances;
b) Supervise effectively, the enforcement of the law relating to medicines and allied substances in order to discover and prosecute persons who violate or contravene it,
c) Supervises timely Local and International GMP inspections of premises for manufacture of medicines and allied substances in order to achieve compliance;
d) Supervise effectively, the processing of applications for import and export authorisation in order to facilitate their issuance;
e) Co-ordinate effectively, the authorisation and monitoring of import, export, manufacture, labeling, advertisements and promotion of medicines and allied substances in order to ensure the quality, safety and efficacy of medicines and allied substances;
f) Supervise timely and effectively, product sampling screening in order to facilitate product testing and sample evaluation;
g) Supervise licensing of pharmaceutical premises and facilities on the IRIMS platform in order to ensure effectiveness of service delivery and turnaround time;
h) Supervise effectively, the implementation of the quality management system in the Department
in order to maintain required standards of service delivery,
i) Coordinates effectively, the planning and undertaking of pharmacovigilance activities in order to monitor the safety of medicines and allied substances on the market:
j) Supervise effectively, the control of manufacture, import, export, storage, distribution, supply, dispensing, sale and disposal of psychotropic substances, narcotic drugs and precursor chemicals in order to ensure that the products are made available for licit use:
k) Supervise effectively, the investigations relating to medicines and allied substances in order to facilitate decision making;
l) Participates in the preparation of the overall ZAMRA Budget in a timely manner and with consideration to high quality standards, in order to ensure timely allocation of sufficient resources for the implementation of the ZAMRA strategy:
m) Supervise development of departmental policies and procedures in order to provide guidelines for effective provision services; and
n) Supervise effectively the implementation of performance management in order to facilitate improvement in performance and productivity.

2.0 DIRECTOR – LICENSING SURVEILLANCE & ENFORCEMENT (1)
Job Purpose
To Direct the issuance of the licences, certificates and permits for premises used for the manufacture, storage, distribution and sale of medicines and allied substances in order to achieve compliance to set standards in accordance with the policy guidelines.

Person specifications and Qualifications
a) Full Form V/ Grade 12 School Certificate (including English and Mathematics);
b) Bachelor of Pharmacy Degree/ Bachelor of Veterinary Medicine /or any related Science;
c) Membership to relevant professional bodies; and
d) 10 years experience of which 5 years at managerial level. Required Skills and Attributes
a) Proficiency in computer skills
b) Good analytical skills;
c) Good planning and organization skills,
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Good communication skills.
g) Must be conversant with Microsoft packages; and
h) Good report writing skills.

Duties and Responsibilities
a) Supervise effectively, licensing of pharmaceutical premises and facilities in order to safeguard the integrity of medicines and allied substances;
b) Manage effectively, the enforcement of the law relating to medicines and allied substances in order to discover and prosecute persons who violate or contravene it;
c) Manages timely and effectively, Local and International GMP inspections of premises for manufacture of medicines and allied substances in order to achieve compliance to set standards;
d) Manage effectively, the processing of applications for import and export authorisation in order to facilitate their issuance;
e) Supervise the authorisation and monitoring of import, export, manufacture, labeling, advertisements and promotion of medicines and allied substances in order to ensure the quality, safety and efficacy of medicines and allied substances;
f) Manage the timely sampling of products in order to facilitate medical product screening, testing and evaluation;
g) Manage licensing of pharmaceutical premises and facilities on the IRIMS platform in order to ensure effectiveness of service delivery and turnaround time;
h) Manage effectively, the implementation of the quality management system in the Department in order to maintain required standards of service delivery:
i) Manage effectively, the control of manufacture, import, export, storage, distribution, supply, dispensing, sale and disposal of psychotropic substances, narcotic drugs and precursor chemicals in order to ensure that the products are made available for licit use;
j) Manage effectively, the investigations relating to medicines and allied substances in order to facilitate decision making.
k) Supervise the preparation of the Departmental ZAMRA Budget in a timely manner and with
consideration to high quality standards, in order to ensure timely allocation of sufficient resources for the implementation of the ZAMRA strategy;
l) Supervise development of departmental policies and procedures in order to provide guidelines for effective provision services; and
m) Supervise the implementation of performance management in order to facilitate improvement in performance and productivity.

3.0 ASSISTANT DIRECTOR – MARKETING AUTHORIZATION (1)
Job Purpose
To effectively supervise registration of human and veterinary medicines, pharmacovigilance, clinical trials, allied substances in order to achieve compliance to set standards of quality, safety and efficacy

Person Specifications and Qualifications
a) Full Form V/Grade 12 School Certificate (including English and Mathematics),
b) Bachelor of Pharmacy Degree/ Bachelor of Veterinary Medicine for any related Science:
c) Membership to relevant professional bodies, and
d) 8 years’ experience of which 3 years at managerial level.

Required Skills and Attributes
a) Proficiency in computer skills;
b) Good analytical skills;
c) Good planning and organization skills:
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Good communication skills;
g) Must be conversant with Microsoft packages; and
h) Good report writing skills.

Duties and Responsibilities
a) Supervise effectively, the evaluation of medicines and allied substances for human and animal use for grant of marketing authorisation;
b) Supervise effectively, capacity building and development programmes for staff in order to impart requisite knowledge and skills;
c) Supervise regularly, the development, review and dissemination of market authorisation and clinical trials guidelines in order to provide information to potential applicants and staff.
d) Supervise effectively, the processing of applications for clinical trials and auditing of clinical trial sites involving medicines and allied substances in order to facilitate the
issuance of certificates and compliance to Good Clinical Practices;
e) Coordinates effectively, the planning and undertaking of pharmacovigilance activities in order to monitor the safety of medicines and allied substances on the market;
f) effectively, the classification and storage of dossiers and samples in order to facilitate their retrieval, laboratory analysis and decision making:
g) Supervise effectively, the maintenance of the medicines information management system in order to facilitate storage, processing, retrieval and dissemination of information,
h) Supervise effectively the implementation of performance management systems in order to facilitate improvement in performance and productivity; and
j) Supervise effectively, the utilization of human, material and financial resources in order to facilitate realization of departmental goals.

Required Skills and Attributes
a) Proficiency in computer skills:
b) Good analytical skills;
c) Good planning and organization skills;
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Good communication skills;
g) Must be conversant with Microsoft packages; and
h) Good report writing skills.

4.0 INSPECTOR GDP & ACCESS (7)
JOB PURPOSE
To undertake registration of pharmacies and issuance of licences and permits for premises used for the storage, distribution and sale of medicines and allied substances in order to achieve compliance to set standards in accordance with the policy guidelines.

Person Specifications and Qualifications
a) Full Form V/ Grade 12 School Certificate (including English and Mathematics).
b) Bachelor of Pharmacy Degree/ Bachelor of Veterinary Medicine /or any related Science:
c) Membership to relevant professional bodies, and
d) 3 years post qualification experience

Required Skills and Attributes
a) Proficiency in computer skills,
b) Good analytical skills;
c) Good planning and organization skills,
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Good communication skills, and
g) Good report writing skills.

Duties and Responsibilities
a) Undertake timely, inspections of premises for retail pharmacies, hospital pharmacies, importers/exporters, wholesale dealers, health shops and agro-veterinary shops of medicines and allied substances in order to ensure compliance with licensing terms;
b) Undertake timely, processing of applications for pharmaceutical establishments and facilities in order to facilitate the issuance of licence, certificates and permits;
c) Undertake effectively, the regulation of medicines and allied substances disposal in order to ensure their safe destruction;
d) Undertakes effectively, the processing of applications for import and export authorisation in order to facilitate their issuance;
e) Perform and maintain timely, the validation of data entered on to the database in order to ensure accurate reporting:
f) Manage effectively the implementation of performance management systems in order to facilitate improvement in performance and productivity; and
g) Supervise effectively, staff in order to ensure the attainment of the department’s objectives.

5.0 SENIOR STRATEGY OFFICER (1)
Job Purpose
To assist in the achievement of the Authority strategic objectives, policies, standards and
operational outputs.

Person Specifications and Qualifications
a) Full Form V/ Grade 12 School Certificate (including English and Mathematics);
b) Bachelors of Degree in either Business Studies or Social Sciences;
c) Postgraduate in Strategic Management an added advantage;
d) 5 years experience of which 3 years at managerial level; and
e) Track record of building and successfully implementing strategy in complex Organisations
with a wide variety of stakeholder interests

Required Skills and Attributes
a) Proficiency in computer skills;
b) Good analytical skills;
c) Good planning and organization skills;
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Good communication skills;
g) Understanding of strategic planning tools;
h) Must be conversant with Microsoft packages; and
i) Good report writing skills.

Duties and Responsibilities
a) Analyze strategy and business plan and how it relates to work, by planning and delivering internal communications activity for the team and by supporting quarterly corporate performance reporting:
b) Provide project management support for Authority corporate planning process, and provide ongoing advice and support to assist teams develop credible plans to effectively implement
the strategy.
c) Assist to bring together and analyse internal and external data, to provide Management with the information required to make strategic decisions;
d) Ensure executive focus on measurable impact across the Authority’s objectives;
e) An ability to listen to and challenge diverse opinion, synthesise complex data and clearly communicate the Authority’s strategy to internal and external stakeholders,
f) Ensure that strategic actions are completed at various levels to achieve desired organizational goals and initiatives:
g) Ensure that the organization maintains appropriate metrics to measure performance and progress towards strategic goals;
h) Design and lead complex projects and activities to achieve operational and strategic
outcomes,
i) Investigate information from a variety of sources, undertake critical analysis and form logical and accurate advice and strategies and align operational activities accordingly.
j) Contribute to the formulation, implementation and evaluation of departmental strategic and operational plans and performance,
k) Develop and implement strategies, builds capability and establishes systems and processes to support Organisational objectives; and
l) Inspire a sense of purpose and direction, with the ability to shape and influence activity in support of Organisation goals and values.

6.0 PRINCIPAL LEGAL OFFICER-ADVISORY AND LITIGATION (1)
Job Purpose
Under the Supervision of the Director Legal/Board Secretary assist with provision of legal services to the Authority in order to protect the Authority against unwarranted litigations, as well as ensuring that operations of the Authority are within the law.

Person Specifications and Qualifications
a) Full Form V or Grade 12 School Certificate or equivalent qualification verified and approved by Zambia Qualifications Authority.
b) Bachelor of Laws (LLB);
c) Post graduate Diploma in Legislative Drafting:
d) Master’s Degree in Law (LLM) will be an added advantage;
e) Advocate of the High Court of Zambia with a minimum of 5 years’ post qualifying experience;
f) Members of Law Association of Zambia (with current practicing certificate).

Required Skills and Attributes
a) Excellent Knowledge of High Court and Supreme Court Rules
b) Strong litigation and advocacy skills;
c) Legal drafting skills;
d) Proficiency in computer skills,
e) Good analytical skills;
f) Good planning and Organisation skills;
g) Ability to work under minimal supervision;
h) Good interpersonal skills;
i) Good communication skills;
j) Good report writing skills; and
k) Ability to handle confidential and sensitive information.

Duties and Responsibilities
a) Advise on the interpretation of relevant statutes to ensure operations of the Authority are within the provisions of the law;
b) Prepare timely legal opinions on matters of interest to enable the Authority to make informed decisions concerning various litigation cases and other legal matters;
c) Undertake timely review and drafting of contracts, agreements, memorandum of understanding, policies, guidelines and other legal documents as required;
d) Represent the Authority in a relevant court, Commission, tribunal or other similar body in
any matter where the Authority is a party or shall be affected by a decision of such a relevant court, Commission, tribunal or other similar body;
e) Attend to all litigation matters including the drafting of appropriate court process,
interlocutory applications and generally to safeguard the interests of the Authority and other stakeholders in all court cases to ensure that favorable judgments are recorded where the Authority has initiated the litigation or defends the matter;
f) Prepare all case work for court litigation, mediation, arbitration or ex-curia settlement which ever may occur,
g) Identify and arrange appropriate witnesses for pretrial briefs internally and with external counsel where applicable;
h) Review judgements, pronouncements, determination of the judicial bodies and advise the Authority on the effects of such decisions on the operations of the Authority;
i) Advise the Authority on changes and development in legislation, regulations, guidelines and practices affecting the operations of the Authority,
j) Liaising with relevant authorities and facilitate the drafting of the relevant statutory instruments, possible amendments, guidelines and other legal documents;
k) Supervises and undertakes effectively the prosecution of offences under the Medicines and Allied Substances Act No. 3 of 2013 to foster compliance with the law;
l) Provide efficient and effective legal risk management support in form of monitoring and compliance with internal policies and relevant legislation;
m) Provide regular status reports to appraise management on the status of legal cases and other legal matters; and
n) Perform other incidental duties as may be assigned by the Director Legal/ Board Secretary

7.0 LEGAL OFFICER – PROSECUTIONS (1)
Job Purpose
To ensure adherence with the provision of the Medicines and Allied Substances Act No. 3 of 2013 and all other related legislation by prosecuting individuals and entities for breaches and offences under the said Act.

Person Specifications and Qualifications
a) Full Form V or Grade 12 School Certificate or equivalent qualification verified and approved by Zambia Qualifications Authority.
b) Bachelor of Laws (LLB);
c) Advocate of the High Court of Zambia with a minimum of 2 years’ post qualifying experience;
d) Members of Law Association of Zambia (with current practicing certificate)

Required Skills and Attributes
a) Strong litigation and advocacy skills.
b) Proficiency in computer skills;
c) Good analytical skills,
d) Good planning and organization skills:
e) Ability to work under minimal supervision;
f) Good interpersonal skills;
g) Good communication skills;
h) Good report writing skills; and
i) Ability to handle confidential and sensitive information.

Duties and Responsibilities
a) Provide legal opinions and advise on the interpretation of relevant statutes to ensure operations of the Authority are within the provisions of the law;
b) Undertake timely review and drafting of contracts, agreements, memorandum of understanding, policies, guidelines and other legal documents as required;
c) Represent the Authority in a relevant court, Commission, tribunal or other similar body in any matter where the Authority is a party or shall be affected by a decision of such a relevant court Commission, tribunal or other similar body;
d) Undertake effectively the prosecution of offences under the Medicines and Allied Substances Act No. 3 of 2013 to enforce compliance with the law,
e) Identify and anange appropriate witnesses for pretrial briefs internally and with external counsel where applicable,
f) Liaise with criminal justice system agencies/stakeholders during case preparation and
prosecution;
g) Review judgements, pronouncements, determination of the judicial bodies and advise the Authority on the effects of such decisions on the operations of the Authority:
h) Preparing regular status reports on prosecuted cases; and
i) Perform other incidental duties as may be assigned by the supervisor.

8.0 MAINTENANCE OFFICER (1)
Job Purpose
To effectively maintain the Authority office complex by ensuring the external vendors are effectively supervised in order to provide a conducive working environment.

Person Specifications and Qualifications
a) Full Form V/ Grade 12 School Certificate (including English and Mathematics);
b) Bachelor of Science Degree in Civil Engineering or any relevant Degree;
c) Membership to Engineering Institution of Zambia (EIZ); and
d) 5 years’ experience.

Required Skills and Attributes
a) Proficiency in computer skills;
b) Good analytical skills,
c) Good planning and organization skills;
d) Ability to work under minimal supervision,
e) Good interpersonal skills,
f) Good communication skills, and
g) Good report writing skills.

Duties and Responsibilities
a) Prepare annual work maintenance plans and budgetary requirements;
b) Carry out checks and inspections as necessary to ensure equipment is safe, reliable and well maintained;
c) Conduct routine inspections of the premises and equipment;
d) Ensure basic maintenance and repair works are performed:
e) Carryout repairs and maintenance tasks on a range of equipment, furniture, buildings and facilities:
f) Proactively identify maintenance and repair tasks needed and carryout the necessary maintenance or report for action by others;
g) Ensure all electrical, plumbing, painting, general maintenance works are attended to timely and efficiently;
h) Supervise maintenance works from contracted company in accordance with service contract terms and conditions; and
i) Comply with relevant legislation policies and procedures, applicable to the role.

9.0 CALL CENTRE OFFICER (1)
Job Purpose
To professionally respond to telephone inquiries from callers and ensuring customer satisfaction by providing quality service and assisting them with issues/concerns related to service delivery.

Person Specifications and Qualifications
a) Full Form V/ Grade 12 School Certificate (including English and Mathematics);
b) Bachelor of Marketing/Public Relations/Mass Communication or any related Degree:
c) Membership to relevant professional body, and
d) 3 years’ experience.

Required Skills and Attributes
a) Proficiency in computer skills;
b) Good analytical skills;
c) Good planning and organization skills;
d) Ability to work under minimal supervision;
e) Good interpersonal skills;
f) Strong customer service skills;
g) Good communication skills;
h) Good report writing skills;
i) Ability to handle confidential and sensitive information; and
j) Must be able to handle multiple tasks, complexity, and diversity of customers.

Duties and Responsibilities
a) Answer telephone calls promptly and in a polite and professional manner;
b) Provide customers with service information in line with service delivery Charter;
c) Handle customer complaints or issues;
d) Document all call information according to standard procedures;
e) Identify and escalating issues relating to customer and service delivery to supervisors as needed;
f) Follow up on customer inquiries not immediately resolved;
g) Direct calls to other departments as necessary;
h) Ensure that work assignments and information gathered from day to day work is not
shared with anyone and protects all customer and Authority information, and
i) Follow up with rescheduling missed appointments as assigned

Education Requirement: No Requirements

Job Experience: No Requirements

Work Hours: 8

Experience in Months:

Level of Education:

Job application procedure
• Interested candidates should send applications with copies of detailed Curriculum Vitae, Grade 12 Certificate, Degree Transcript of results, Professional registration membership and valid practicing licence to:-
• The Director-General
Zambia Medicines Regulatory Authority
Plot No. 2350/M, Off KKIA Road
P.O. Box31890
LUSAKA
• NOTE: Candidates are required to have their qualifications verified by the Zambia Qualifications Authority (ZAQA) before submitting their application.
• Envelopes should be appropriately marked with the position applied for.
• The deadline for receipt of applications is Monday 21 October 2024. Only shortlisted candidates will be contacted for interviews. ZAMRA is an equal opportunity employer, and we encourage applications from qualified individuals of all backgrounds

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