Pharmaceutical Registration, Importation and Regulation Consultant

Chemonics International Inc. JOB DESCRIPTION/SCOPE OF WORK Position Title: Pharmaceutical Registration, Importation and Regulation Consultant Classification: FO ST Professional – Independent Consultant This scope of work (SOW) sets forth the services to be provided by the Consultant to Chemonics International Inc. Background: The purpose of the USAID Global Health Supply Chain Program – Procurement and Supply Management (GHSC-PSM) project is to ensure uninterrupted supplies of health commodities in support of USG-funded public health initiatives around the world. The project provides direct procurement and supply chain management support to the President’s Emergency Plan for AIDS Relief (PEPFAR), the President’s Malaria Initiative (PMI), and Population and Reproductive Health (PRH), and the Office of Maternal and Child Health and Nutrition (MCH). In supporting USG-funded global health activities, GHSC-PSM will develop and manage a wide array of services for health commodity procurement and related systems strengthening technical assistance encompassing different elements of a comprehensive supply chain. In Vietnam, GHSC-PSM performs work under the HIV/AIDS Task Order. GHSC-PSM in Vietnam supports country strategies and priorities that fall under the following three project objectives:

Global Commodity Procurement and Logistics
Systems Strengthening Technical Assistance
Global Collaboration to Improve Long-Term Availability of Health Commodities.

GHSC-PSM in Vietnam is supporting the Ministry of Health with the implementation of COP19 PEPFAR directives aimed at greater efficiencies and effectiveness in HIV/AIDS program activities. In order to support the Multi-Month Scripting (MMS) model rolling out, GHSC-PSM will advocate for Government of Vietnam partners and suppliers to register larger pack sizes of ARV products for the Vietnam market and facilitate the availability of ARVs with pack size of 90 and or 180 count, including registration and procurement planning. On October 23, 2019 the Drug Administration of Vietnam issued decision 653/QD-QLD approving the Marketing Authorization of Tenofovir disoproxil fumarate-Lamivudine-Dolutegravir 300/300/50 (TLD), which is valid for three years. TLD and Tenofovir disoproxil fumarate-Lamivudine-Efavirenz (TLE) are listed in the National HIV/AIDS Treatment Guidelines (Ministry of Health decision 5418/QD-BYT dated 1/12/2017) as the preferred and alternate first-line regimen. GHSC-PSM therefore requires a local consultant to advise on pharmaceutical registration and importation, specifically in regard to facilitate the pack size ARVs of 90 counts/180 counts of TLD and TLE400 registration and importation. Objective: The Pharmaceutical Registration, Importation and Regulation Consultant will work closely with VAAC, the Drug Administration of Vietnam (DAV)/Ministry of Health, GHSC-PSM and its local contractor, Central Pharmaceutical Company (CPC1) JSC, potential ARV suppliers to successfully get TLD, TLE registered the pack size 90/180 count and consult on other pharmaceutical issues as requested Principal Services and Responsibilities (Essential Functions) The Consultant for Pharmaceutical Registration, Importation and Regulation will be responsible for the following principal services and responsibilities:

Advise on regulations and procedures to register and import TLD, TLE400 with 90/180 counts and other medicine (when required) into Vietnam successfully;
Work closely with GHSC-PSM, local contractors, and related stakeholders in consolidating and reviewing documents for filling an amendment of pack-sizes of 90/180 counts for Market authorization (MA) and/or import permits;
Coordinate regularly with the Drug Administration of Vietnam (DAV)/Ministry of Health to follow up on and facilitate the Marketing Authorization approval of TLD/TLE400’s pack-size 90/180 counts or import permit; or any other issue related to TLD, TLE400 or other ARV.
Consult on other pharmaceutical issues as requested.

Required Skills and Qualifications:

A bachelor’s degree in pharmacy or medicine is required
A minimum of 5 years of experience in drug registration and importation permits
Working experience with the Drug Administration - Ministry of Health and international donor-funded projects are preferred
Excellent interpersonal and communications skills
Fluency in Vietnamese and advanced English required

Supervision of Consultant: The Pharmaceutical Registration, Importation and Regulation Consultant will report to the Technical Director. Period of Performance: March 1, 2020 to September 30, 2020 Level of Effort: 42 working days. The consultant is not allowed to bill more than 8 hours per day on a five-day work week. Location: Hanoi, Vietnam Application Instructions Send electronic submissions to psmvietnamrecruit@gmail.com by 5pm February 25th, 2020 with only "Pharmaceutical Registration, Importation and Regulation Consultant" in the subject line. Finalists will be contacted. Chemonics is an Equal Opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, or protected veteran status, genetic information, age, membership in an employee organization, or other non-merit factors

Tags: Chemonics