Job Description
Background: The Family Planning Association of Sri Lanka (FPA Sri Lanka), the pioneer in Family Planning and Reproductive Health Education, is an accredited member of the International Planned Parenthood Federation (IPPF) in the United Kingdom.
SRI LANKA enriching relationships
CONSULTANCY | Product Registration PrEP & HIV - self testing
Project Background: The Sustainability of HIV Services for Key Populations in South-East Asia (SKPA-2) is a three-year multi-country grant funded by the Global Fund to Fight AIDS, Tuberculosis and Malaria for the period of 1 July 2022 to 30 June 2025. The SKPA-2 programme - which follows and significantly extends the SKPA-1 programme - aims to improve the sustainability of evidence-informed, prioritized HIV services for key populations in Bhutan, Mongolia, Philippines, and Sri Lanka.
In Sri Lanka, the SKPA-2 program is being implemented by the Family Planning Association (FPA) of Sri Lanka as the sub recipient, which works in partnership with the National STD/AIDS Control Programme of Sri Lanka (NSACP) and other local and regional partners organizations, including community-led organizations.
The SKPA-2 Programme has four programme objectives:
1- Accelerate financial sustainability;
2- Improve strategic information availability and use;
3- Promote programmatic sustainability;
4- Remove human rights and gender-related barriers to services.
Consultancy Objectives:
Pre-Exposure Prophylaxis (PrEP) and HIV self-testing are not available in Sri Lankan private market and it is only available through government entities. The consultancy aims to assess the current landscape and identify strategic entry points for the scale-up of Pre-Exposure Prophylaxis (PrEP) and HIV self-testing. This includes mapping out processes and activities necessary to integrate PrEP into national health systems and ensuring its inclusion in strategic plans, drug registries, essential medicines lists, and national guidelines. Additionally, the consultancy will support and provide necessary inputs for the targeted demand generation campaigns and assess and enhance supply chain systems to enable expanded access to PrEP for all key populations. The ultimate goal is to work closely with the Family Planning Association of Sri Lanka (FPASL) and the National Medicines Regulatory Authority (NMRA) to make PrEP and HIV self-testing registered and available in the private market with easy access to the public.
Expected Outcomes of the Consultancy:
The primary tasks of this consultancy are to provide essential support and guidance to the Family Planning Association of Sri Lanka (FPASL) and facilitate coordination between FPASL and the National Medicines Regulatory Authority (NMRA) throughout the product registration process. The consultancy will commence with a thorough desk review and situational assessment to delineate and map out the product registration process. It will further entail coordination with suppliers to compile requisite documentation, in collaboration with FPASL, and liaise with NMRA to align with their registration requirements. Additionally, the consultancy will oversee and facilitate meetings with pertinent government stakeholders, including the Ministry of Health (MOH). The consultancy will ensure the inclusion of Pre-Exposure Prophylaxis (PrEP) and HIV self-testing in the national drug registry, essential medicines list, and national guidelines.
Demand-generation: Contribute to and review the demand-generation campaign, providing essential insights to enhance the visibility and acceptance of PrEP and HIV testing among the target population.
Mission-Related Travel: These visits may include activities such as situational assessments, and meetings with stakeholders and implementers. Travel plans must be agreed upon in writing with the Health Equity Matters and the Family Planning Association of Sri Lanka teams.
Deliverables
The due dates for the deliverables will be agreed upon with the selected candidate(s), Health Equity Matters, and FPA-Sri Lanka. The LOE for each deliverable and output is outlined in the table below.
Deliverables/Outputs
Map out the process in a detailed work plan for the implementation of the consultancy
Sign the contract
Situational analysis is a brief report on the challenges and bottlenecks with recommendations
Identify potential stakeholders and suppliers Consultations with government stakeholders (e.g., MoH, NMRA), health care workers, and Sri Lankan key population-led civil society organizations.
Liaise with the officials of the Ministry of Health and arrange necessary meetings to obtain necessary authorization Prepare the required documentation and Register the PrEP and HIV-self testing at NMRA from a supplier selected by FPA Sri Lanka and Verify documents in the dossier
Obtain sample license
PrEP and HIV-Self testing included in the national drug
Indicative
Responsibility
Timelines
National Expert
Mid-May 2024
National Expert in Late May 2024 support of FPA
National Expert
Early June 2024
National Expert in July 2024 support of FPA
National Expert in July 2024 support of FPA
National Expert National Expert
Aug 2024 Oct 2024
formulary/essential HIV drugs list
Submit it to NMRA and follow up until the product registration is completed
National Expert
Nov 2024- February 2025
Required Qualifications/Experience
Essential
Demonstrated understanding of comprehensive HIV service delivery, HIV testing services including HIVST, community-based testing, and comprehensive HIV responses.
Demonstrated experience in pharmaceutical regulatory affairs, preferably within the context of Sri Lankan product registration processes. Familiarity with national and international regulatory frameworks and requirements is crucial.
Experience with coordinating registration activities, compiling documentation, and liaising with regulatory agencies is necessary.
Understanding of the drug development and registration lifecycle and post-marketing surveillance. Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines is desirable.
Ability to coordinate multiple tasks, meet deadlines, and work effectively in a cross-functional team environment. Experience in managing regulatory projects from inception to completion is preferred. Excellent written and verbal communication skills are essential for drafting regulatory documents, communicating with regulatory agencies, and collaborating with internal and external stakeholders. Strong analytical and problem-solving skills to assess regulatory requirements, interpret guidelines, and address regulatory challenges effectively.
Meticulous attention to detail is crucial for ensuring accuracy and completeness in regulatory submissions and documentation.
Ability to adapt to changing regulatory requirements and navigate complex regulatory landscapes. Flexibility to adjust strategies and approaches based on evolving project needs is important. Demonstrated experience in working collaboratively to resolve complex issues, including with stakeholders who may hold differing views and conflicting interests.
Demonstrated experience in working with key populations and civil society organizations in Sri Lanka. Familiarity with healthcare systems, particularly in Sri Lanka, can provide valuable context for
effectively navigating regulatory processes and requirements.
Able to work within the Colombo, Sri Lanka area and travel to surrounding districts Written and verbal English and Sinhala or Tamil communication skills a plus
Desirable
Experience in HIV responses in Asia and the Pacific, including through programming and policy, capacity development, and institutional strengthening for community organizations. Demonstrated experience working with communities.
Scope of Price and Payment Schedule
We invite you to submit a comprehensive application package to be considered for the position. Here's what you need to include:
Curriculum Vitae (CV): Ensure your CV is current, detailing your professional background, educational qualifications, and any relevant experiences pertinent to this role.
Cover Letter: Your cover letter should articulate your interest in this opportunity, outlining why you believe you are the ideal candidate. Emphasize your unique skills, past achievements, and what motivates you to apply for this position.
Two Referees: List two professional referees who can vouch for your qualifications, work ethic, and suitability for this assignment. Please include their names, their relationship with you, and their contact information (email and phone number).
FPA Sri Lanka is committed to the safety and protection of children, young people and vulnerable adults, and this role may include contact with these groups. Our recruitment and selection procedures reflect our commitment to the safety and protection of children, young people and vulnerable adults in our programs.
FPA Sri Lanka is an equal opportunity employer that will not discriminate on grounds such as Age, Gender, Ethnicity, Religion, Marital Status, and Disability. Please send us your application, on or before the 17th of May 2024, citing two non-related referees. Please note that only shortlisted candidates will be contacted.
The Executive Director
FPA Sri Lanka
37/27, Bullers Lane,
Colombo 07
Or Email to [email protected]
Our website www.fpasrilanka.org
