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Regulatory Officer Consultant

This job is no longer available

Washington, DC, USA
Full-time

PSI is seeking a Regulatory Officer on a Short to Medium Term Assignment to Develop a data bank of Regulatory Requirements of Selling and Distributing Health Commodities in countries where PSI Operates.

Areas of Responsibility: 
  • Landscape & Build a Knowledge Bank of Pharmaceutical (Ethical, Medical Devices & Medical Equipment’s) Product Registration Process, Dossier Requirements and time lines for registration in:
    • PSI operational countries (Phase -I)
    • Countries in regions where PSI operates but not present operationally in specific country (Phase II)
  • Explore and recommend Opportunities in Regulatory Registration through Regional, World Health Organization and any other Harmonization Schemes. Layout success stories, challenges and learnings of these Harmonization Schemes.
  • Explore and recommend potential Organizations/Experts for Pharmaceutical Registration at country level, regional level or global level
  • Develop Complexity Map of registration requirement and grade/map individual countries to Complexity Map.
  • Advise Regulatory Structure for Pharmaceutical Registrations with skill set requirements for PSI, based on immediate to long term needs, post discussions with global stakeholders.
  • Advise on opportunities to Harmonize packaging ,artworks across countries.
Educational Background: 
Master’s Degree in Pharmaceutical Science
Skills/Experience: 
  • 2-3 years of experience in Regulatory Department of medium sized Pharmaceutical Organization and having experience in Product Registration in Africa Region
  • Proficiency in English is a must (Spanish or French would be an advantage)
  • Excellent verbal and written communication skills
  • Broad Technical language of pharmaceuticals and their documentation
  • Strong analytical skills with a process approach
  • Ability to coordinate amongst stake holders

What would get us excited?

  • Demonstrated experience to meet Pharmaceutical Registration Challenges in Africa
  • Inquisitiveness to look out for options towards challenges Pharmaceutical Registrations
  • Ability to do SWOT Analysis of a given situation
Job Function: 

Organization Info

Population Services International

Overview
Headquarters: 
Washington, DC, United States
Annual Budget : 
More than $500M
Size: 
10,001+ employees
Founded: 
1971
About Us
Mission: 

PSI makes it easier for people in the developing world to lead healthier lives and plan families they desire by marketing affordable products and services. PSI's global health network of more than 50 local organizations focuses on serious challenges like a lack of family planning, HIV and AIDS, barriers to maternal health, and the greatest threats to children under five, including malaria, diarrhea, pneumonia and malnutrition.

A hallmark of PSI is a commitment to the principle that health services and products are most effective when they are accompanied by robust communications and distribution efforts that help ensure wide acceptance and proper use.

PSI works in partnership with local governments, ministries of health and local organizations to create health solutions that are built to last.

Listing Stats

Post Date: 
Aug 15 2018
Active Until: 
Sep 15 2018
Hiring Organization: 
Population Services International
industry: 
Nonprofit