ABOUT US

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.

PQM+

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 several 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.

ROLE OVERVIEW

USP seeks an experienced regulatory affair professional as a consultant. The consultant will work to provide support for the implementation of regulatory system strengthening activity with DRAP as per the approved workplan. The consultant will also coordinate with DRAP for day-to-day regulatory matters associated with work plan activities. The consultant will provide technical assistance to selected manufacturers/stakeholders for the preparation of the dossier for WHO PQ. Moreover, Under the overall direction of the PQM+ Chief of Party, the Individual will:

KEY RESPONSIBILITIES

• Works hand-in-hand with the COP and team to provide technical advice to selected manufacturers/stakeholders, particularly in good Regulatory Practice, medicines regulation, and development/review of the pharmaceutical quality management system at the manufacturers/stakeholders’ level.
• Assist DRAP in development, Implementation, and review of Institutional Development plan based on WHO GBT self-assessment
• Provide Regulatory assistance to manufacturers/stakeholders on all regulatory aspects.
• Manages specific PQM+ project activities as assigned by the PQM+ Chief of Party and/or the PQM+ HQ Rockville.
• Prepare presentations and training materials, and organize training programs in specialist skills areas.
• Assist the manufacturers in the development and implementation of the CAPA plan.
• Assist manufacturers/stakeholders to formulate and compile dossiers for export.
• Organize training on to develop risk-based post-marketing surveillance (RB-PMS) plan on antimicrobial medicines
• Support DRAP is the development and implementation on CAPA for PIC/s Gap assessment.
• Coordinate and support BE Centers for Real-Time BE Study
• Coordinate with stakeholders and conduct training on AMC Dashboard in PIRIMS
• Support DRAP to conduct self-assessment of medical devices regulation on WHO GBT
• Any other duties assigned by the management

DELIVERABLES (PERIOD OF PERFORMANCE SEPTEMBER, 2023)

1. List of IDPs Implemented
2. CAPA Plan on PIC/s
3. Minutes of Meetings
4. Training Reports & Presentations
5. BE Study Report

Upon Monthly Reports, Submission of Programmatic Deliverables

QUALIFICATIONS

• At least a bachelor’s degree or other professional degrees in pharmaceutical sciences.
• At least eight (08) years of experience in pharmaceutical quality assurance and/or regulatory affairs
• Having experience dealing with regulations WHO PQ/ PICs counties approval of products.
• Having good knowledge of medicine regulations for WHO PQ, PICs, US FDA, EMEA and ICH countries
• Having good knowledge of latest international Guideline in Pharmaceutical field by ICH countries.
• Demonstrated creative problem-solving skills to come up with procedures and policies to deal with issues related to regulatory compliance.
• Demonstrated experience in training and mentoring staff and others.
• Excellent oral and written communication skills in English; knowledge of the local language is desired.
• Good interpersonal skills and teamwork skills with the ability to lead and engage with other project team members and to develop clear policies.
• Working within a quality-focused environment with the ability to deliver against agreed timelines whilst managing workloads and resources to ensure targets are met.
• They also need to have teamwork skills because their work can involve collaborating with other departments.
• Analytical skills are needed to review existing procedures, and they also need to have time management skills to meet deadlines and file paperwork on schedule.

PERIOD OF PERFORMANCE

The anticipated period of performance will be from November 01, 2022, to September 30, 2023. The anticipated contract type is Master Agreement and Work Orders will issue under MCA. The assignment will be required maximum of a 240 Working Days Level of Effort (LOE).

GEOGRAPHIC AREA

The individual will work with the USP Pakistan team based at Islamabad Office.

EVALUATION CRITERIA

1. Previous Experience - 35%
2. Qualification and Education - 40%
3. Financial Proposal- 25%

INSTRUCTIONS

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

IMPORTANT NOTE

Please send CV/, 3-References, and Daily Rate by downloading the following ANNEX – D (Template):

https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing

The Quoted per Day Rate (PKR) should be inclusive of all applicable taxes.

Kindly send all Technical and Financial Proposals to ATTN: USP Pakistan Procurement at [email protected] before the closing date (September 26, 2022). When submitting your application, write “Regulatory Affairs Specialist Consultant” in the email Subject Line.