The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medical products and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.


The Promoting the Quality of Medicines Plus (PQM+) program is a five-year U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance to Medicines Regulatory Authorities in a number of countries in Asia. This cooperative relationship supports the Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems, and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.


USP seeks the services of an international PIC/s Consultant to assist and guide DRAP in preparation for PIC/s and application submission. The consultant will train DRAP staff on PIC/s guidelines and procedures and guide DRAP on structural modifications where required. The Consultant(s) will be called to work on an as-needed basis, under specific Work Orders, and will report to the Consultant Supervisor listed on the Work Order. USP - PQM+ Pakistan team would like to hire a regulatory consultant who will work to provide regulatory system-strengthening support to manufacturers/stakeholders. Under the overall direction of the PQM+ Chief of Party the Individual will:


  1. Support DRAP for CAPA preparations and its implementation as per the gap assessment report
  2. Review the Quality Management System of the DRAP Inspectorate
  3. Review Risk Based inspection system and risk categorization criteria of DRAP for the Industry
  4. Review 03 inspection report of risk-based inspections
  5. Provide Virtual Training for DRAP Staff on PIC/s Standards and guidelines
  6. Provide Virtual Training of DRAP Inspectorate for inspections of Industries
  7. Assessment of CAPA implementation against gap assessment
  8. Support DRAP to submit an application for PIC/s Membership


  1. Finalization of CAPA Plan on gap assessment observation of DRAP
  2. Review implementation of planned CAPA
  3. Review QMS of DRAP Inspectorate and sample inspection reports
  4. Training of DRAP staff on PIC/s Guidelines and Procedures
  5. Training of DRAP inspectors on PIC/s inspection criteria for industries
  6. Preparation and submission of DRAP application to PIC/s.


Submission of Report and Invoice for the Programmatic Deliverables


September 30th 2023


  • At least a master’s degree in Pharmaceutical Sciences.
  • At least Fifteen years of experience in the Pharmaceutical Regulatory System
  • Internationally Proven 5 years experience with PIC/s Member Regulatory Authorities.
  • Hands-on experience and work understanding of the implementation of PIC/s Standards
  • Should have hand on experience with at least 05  countries for PIC/s Membership
  • Demonstrated ability in developing policies, regulations, and guidelines according to PIC/s Standards
  • Demonstrated ability to lead professionals and manage others through influence and collaboration.
  • Demonstrated ability to conduct and interpret quantitative/qualitative information with analytical problem-solving.
  • Proven leadership skills in consulting with demonstrated experience in training and mentoring staff and others.
  • Excellent oral and written communication skills in English; knowledge of the local language is desired.
  • Must demonstrate an understanding of the operations, health policy trends, and any applicable regulations related to the responsible technical area.


The anticipated period of performance will be March 1st, 2023 to September 30th, 2023. The Anticipated Contract Type is a Master Agreement and Work Orders will issue under MCA. The assignment will be required a maximum of 15 Working Days Level of Effort (LOE).


The individual will work with the USP Pakistan team based at Islamabad Office. (Full-Time/Hybrid Mode).


  • Previous Experience - 40%
  • Qualification and Education - 40%
  • Financial Proposal- 20%


The applicant is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.

Job Details

Functional Area:
Total Positions:
1 Post
Job Shift:
Hybrid Work Model
Job Type:
Job Location:
No Preference
Minimum Education:
Degree Title:
At least a master’s degree in Pharmaceutical Sciences
Career Level:
Department Head
Minimum Experience:
15 Years (At least Fifteen years’ experience in Pharmaceutical Regulatory System. Internationally Proven 5 years’ experience with PIC/s Member Regulatory Authorities.)
Apply Before:
Jan 12, 2023
Posting Date:
Dec 27, 2022
Diversity Inclusion:
We value diversity of our employees. All qualified applicants will receive fair consideration without regard to genders or socio-economic backgrounds.

United States Pharmacopeial Convention

N.G.O./Social Services · 1-10 employees - Islamabad

pThe U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. Our mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP envisions a world in which all have access to high quality, safe, and beneficial medicines and foods. USP approaches this vision with a sense of urgency and purpose, strengthened by its cadre of dedicated volunteers, members, and staff, and by working collaboratively with key stakeholders across the globe. As the world gets smaller and more connected, quality issues affect everyone. Diseases travel. Drug resistance grows. Fake medicines kill. The foundation of quality we’re building helps address these and other global health issues. Whether decreasing the prevalence of substandard and poor-quality medicines or helping to curb antimicrobial resistance, we’re there working to protect the health of people all over the world./p

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