STC to support in drug registration activities to the Fiji Medicines Regulatory Authority

BACKGROUND

Strengthening regulation of medical products contributes in the achievement of universal health coverage (UHC) by ensuring the quality, safety and efficacy of medical products before being used by the public.

Drug product registration is the process by which a country’s regulatory authority assesses the safety, quality and efficacy of medicines available to its citizens and is key in protecting public health.

Fiji MRA assessment following WHO’s Global Benchmarking Tool (GBT) highlighted product registration as a priority area of action and in need for support. The Fiji MRA has been preparing to set up its Drug Registration program over the years, however, there is still a need to support capacity building activities for Fiji MRA staff in this area and make the organization able to develop and start its own registration system.

PURPOSE/SPECIFIC OBJECTIVE OF THE ACTIVITY

Review current legislation for medical products’ registration in Fiji and develop an implementation plan, including a Product Registration guideline , SOPs, list of registered products, training material and further recommendations to Fiji Medicines Regulatory Authority (MRA)

DESCRIPTION OF ACTIVITIES TO BE CARRIED OUT

The selected consultant is expected to work with in collaboration with WHO Division of Pacific Technical Support (DPS) and Fiji Medicines Regulatory Authority by:

-      Desk review of pertaining legislation and regulation for medical products in Fiji;

-      Discuss the results of the assessment with WHO DPS, Fiji NRA and Ministry of Health and Medical Services (MHMS) and provide recommendations on the way forward;

-      Develop an implementation plan for drug registration that will include guidelines, SOPs, training materials, etc.

-      Support training activities of Fiji NRA staff (Office of the Chief Pharmacist and Fiji NRA personnel)

METHODS TO CARRY OUT THE ACTIVITY

Output 1: Implementation plan

Deliverable 1.1: legislation review and writing of assessment report on drug registration system

Deliverable 1.2: Implementation plan on drug registration activities and recommendations, together with supportive documentation such as guidelines for product registration, SOPs and working instructions, HR Plan, calendar timeframes, etc.

QUALIFICATIONS & EXPERIENCE

EDUCATION

Essential:  University degree in pharmacy or other medical sciences.

Desirable: Postgraduate qualification (MsC or PhD) in pharmaceutical legislation, or regulatory affairs; Regulatory Affairs Professional Society Certification (RAC) will be considered

EXPERIENCE

Essential: Minimum of seven years of experience in pharmaceutical and medical products regulation, especially in supporting initial marketing authorization (product registration) at international level and experience in working in the area of regulatory convergence and cooperation.

Desirable: Experience working with National Regulatory Authorities in LMIC and Small Island Developing States (SIDS)

TECHNICAL SKILLS & KNOWLEDGE

Demonstrated expertise and good knowledge on pharmaceutical regulatory system and framework; experience supporting and providing guidance to drug registration activities in resource-limited contexts; good interpersonal skills and capable of facilitating discussion and teamwork and  good analytical thinking and writing skills.

Desirable: Experience working in the Pacific or, at least, in SIDS.

LANGUAGES

Essential: Fluent in English

COMPETENCIES

Teamwork, Respecting and promoting individual and cultural differences, Communication, Knowing and managing yourself and producing results.

ADDITIONAL INFORMATION:

Duration of contract: 1/10/21 – 31/12/21

APPLICATIONS

Qualified and interested specialists should submit their CV {for individual contractors} or Company Profile {for institutional applications} and Expression of Interest {cover letter} to the Supply Officer through WP RO UNGM at < wproungm@who.int > by 11 September 2021. 

The cover letter should outline how their experience and qualifications make them a suitable candidate for this position and should include their proposed daily consultancy fee and availability.

Please use Tender Notice No. 140831 as subject to all submission. Only successful candidates will be contacted.