Consultant - Regulation of medical products – product registration/marketing authorization

Area of expertise

Regulation of medical products – product registration/marketing authorization

Purpose of consultancy

Support Regulatory Systems Strengthening program in its activities related to medical product registration and marketing authorization as part of the initial phases of operationalization of the Pasifika MedPro Regulatory Collaboration.

Background

The mission of the Pacific Health Systems and Policy (PHS) team is to support Member States in the Pacific to attain universal coverage of health services for better and equitable health outcomes. Health sector development acts as the foundation that both underpins and unifies public health efforts aimed at combating diseases and building healthy communities in an efficient and equitable manner, especially for high priority, excluded and underserved population groups. A strong health system foundation enables effectiveness of individual programmes and efficient use of shared system resources for all programmes.

Access to safe, effective, quality and affordable essential medicines is important in achieving universal health coverage (UHC) and the Sustainable Development Goals (SDGs) and it’s one of the pillars of every health system.
In the Pacific island countries (PICs) there are many challenges on access to essential medicines, including, availability, affordability, and quality and safety due in part to geographical challenges and weak pharmaceutical systems. Most countries do not have fully functional regulatory systems in place and weak procurement and supply chain management often lead to low availability and wastage of essential medicines.

The Action Agenda on Regulatory Strengthening, Convergence and Cooperation for Medicines and the Health Workforce endorsed by the Member States at the 68th Regional Committee Meeting supports regulatory strengthening, convergence and cooperation in countries. The PICs can benefit from sub-regional regulatory cooperation as most are unable to build and sustain fully functional regulatory authorities due to constraints in human and financial resources.
The establishment of a subregional regulatory platform to strengthen and perform regulations of medicines, vaccines and other pharmaceuticals in the PICs was endorsed by health leaders from across the Pacific at the 13th Pacific Health Ministers Meeting (PHMM) in French Polynesia.

In February 2023, WHO DPS organized a subregional regulatory meeting, where Pacific Member States reiterated a timely, robust and effective technical support required for countries at national, cross-country and subregional level to perform regulatory functions, with a focus on product entry and post-marketing surveillance. In order to improve PICs technical support, RSS unit need to engage with a consultant with expertise in product registration to ensure country assistance without delays.
The work of the consultant will be to support Member States in the Pacific and coordinate and collaborate with counterparts National Regulatory Authorities to implement country and subregional activities that can strengthen pharmaceutical system in the Pacific, with a focus on product registration.

Deliverables

The contractor/s will support Member States to implement country and subregional activities related to medical product registration.
Under the direct supervision of the Technical Officer (Regulatory Systems Strengtening) and overall guidance of the Team Coordinator (PHS), EMT team at WPRO and other WHO teams, the consultant/s will deliver the following (individual activities/combination of some activities based on countries and/or subregional priorities):

Output 1: Provide expert technical guidance in aspects related to setting up and developing product registration/marketing authorization systems:
• Deliverable 1.1: To facilitate drafting of respective laws, regulations, guidelines and SOPs related to import control, product registration or listing in selected PICs (at least 2 PICs). Expected
by end of March 2024
• Deliverable 1.2: To facilitate guidance and provide support in product dossier assessment or review of regulatory documentation during product registration/product listing in selected PICs (at least 2 PICs). Expected by March 2024

Output 2: Provide technical support in setting up databases or information systems related to product registration/import control
• Deliverable 2.1: Contribute in the development of databases and softwares at national level for the registration and management of medical products in selected PICs (at least 2 PICs).
Expected by May 2024

Output 3: Support setting up product registration systems at subregional level
• Deliverable 3.1: To facilitate circulation for endorsement and piloting of the subregional framework for product registration in selected PICs (at least 2 PICs). Expected by end June 2024
• Deliverable 3.2: To facilitate and deliver training sessions around medical product registration, listing, import control and/or verification of sameness to selected PICSs. Expected by end
July 2024

The STC is expected to submit monthly progress report for the duration of the contract and a final technical report with achievements across the contract.

Qualifications, experience, skills and languages

Educational Qualifications:

Essential: Advanced university degree in pharmaceutical sciences, medicine, or relevant health discipline with postgraduate degree in a relevant field from a recognized university.
Desirable: Postgraduate qualification (MsC or PhD) in Pharmaceutical regulatory affairs; Regulatory Affairs Professional Society Certification (RAC)

Experience

Essential: Minimum of seven years of experience in pharmaceutical and medical products regulation, including product registration and dossier assessment, at international level.
Desirable: Experience in providing technical assistance to National Regulatory Authorities in developing countries and Small Island Developing States (SIDS). Experience in revising/updating medical product registration processes, including the development and implementation of electronic registration systems. Experience in regulatory convergence and cooperation initiatives.

Skills/Knowledge:

Essential:
• Experience working in regulation of medical products in low- and middle-income countries
• Computer literacy (Word, Excel, Power Point etc)
• Good interpersonal skills and capable of facilitating discussion and teamwork
• Good analytical thinking and writing skills

Languages and level required (Basic/Intermediate/Expert):

Essential:
Expert knowledge of English

Location

Home-based

Travel

The consultant is expected to travel to Pacific Island Countries on selected missions on request from Countries

Remuneration and budget (travel costs are excluded):

a. Remuneration: Band level B; amount of daily or monthly averages in full

b. Living expenses: Not applicable for offsite (position will be home-based) and onsite for insurance purposes

c. Expected duration of contract (Maximum contract duration is 11 months per calendar year):
11 months (January – November 2024)
Part-time (only 10 working day per month)

Additional Information

This vacancy notice may be used to identify candidates for other similar consultancies at the same level.

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