Hi, I’m
WAQAS AHMED
Rockville,United States
Summary
Global health and regulatory affairs leader with over 21 years of experience strengthening pharmaceutical regulatory systems, supply chain resilience, and laboratory networks in low- and middle-income countries. Skilled in advancing WHO Global Benchmarking Tool (GBT) maturity levels of national regulatory authorities, supporting WHO Prequalification and ISO accreditations, and embedding sustainable policies that improve oversight of medicines and health commodities.
Directed large-scale donor-funded programs, including USAID- and WHO-supported initiatives, working with governments, regulators, and global partners to reduce circulation of substandard and falsified medicines, improve post-marketing surveillance, and strengthen supply chain accountability. Recognized for introducing reliance mechanisms, digital regulatory platforms (including designing and implementing interoperable regulatory data platforms), and community-based approaches that expand access to quality-assured medicines, protect public health, and ensure continuity of impact beyond donor support.
Overview
21
years of professional experience
1
Certification
Work History
U.S. Pharmacopeia (USP)
Senior Manager, International Regulatory Policy & Intelligence
04.2025 - Current
Job overview
- Drive USP’s global post-donor regulatory sustainability agenda, ensuring long-term system resilience and governance continuity across LMICs transitioning from donor-funded support.
- Architect strategic regulatory reform roadmaps that translate donor-funded program outcomes into enduring institutional frameworks, national policies, and sustainable financing models.
- Mobilize and direct cross-functional USP teams and global coalitions—including Regional Chapters, WHO networks, and multilateral partners—to embed reliance mechanisms and promote regulatory convergence.
- Lead the design and development of USP’s Regulatory Systems Resource Center, consolidating technical tools, digital frameworks, and best practices to institutionalize donor funded program achievements and support continued capacity strengthening.
- Engage senior regulators, ministries of health, and donors to shape policy dialogue and secure commitments that safeguard medicine quality and prevent regression after donor transition.
- Accelerate digital transformation by expanding adoption of USP’s regulatory platforms for post-market surveillance, inspections, and laboratory quality assessments in priority countries.
U.S. Pharmacopeia (USP)
Senior Technical Advisor & Technical Lead, Regulatory Systems Strengthening
03.2024 - 03.2025
Job overview
- Strengthened national regulatory capacity in 23 countries by guiding NRAs to advance maturity levels on WHO’s Global Benchmarking Tool (GBT), resulting in measurable improvements in regulatory governance and oversight.
- Enabled laboratories to achieve international recognition (ISO/IEC 17025 accreditation and WHO Prequalification), directly improving medicine quality assurance and public confidence in testing systems.
- Accelerated access to quality-assured medicines by supporting manufacturers with WHO prequalification submissions, dossier preparation, and GMP compliance — leading to faster approvals and broader treatment availability.
- Introduced reliance and risk-based pathways (EUA, CRP, joint reviews), reducing regulatory approval timelines and strengthening efficiency of medicine registration systems in LMICs.
- Institutionalized post-market quality surveillance frameworks that integrated regulatory and lab databases, enabling early detection and removal of substandard medicines from the market, thereby protecting patient safety through data-driven decision-making.
- Led and supervised QA for medical product procurement, guiding teams in applying WHO MQAS model and indigenous tools—strengthening compliance, improving procurement quality, and ensuring safer patient access.
- Advanced regional harmonization in Asia and Africa by aligning regulatory practices with global standards (ICH, PIC/S, WHO norms), contributing to faster cross-country approvals and sustainable regional cooperation.
- Contributed to the design and initiation of country-specific assessments aimed at developing tailored RIMS roadmaps, addressing both data and process standards, to guide alignment of digital regulatory platforms with national contexts and promote future interoperability across regulatory functions.
- Led a multidisciplinary team to develop user requirement specifications (URS) and technical requirements for national digital regulatory software solutions, ensuring scalability, security, and alignment with WHO and ISO data models.
- Led a cross-functional team to upgrade the Risk-Based Inspection (RBI) tool based on field feedback, defining technical specifications, coordinating software consultants, and overseeing pilot implementation to strengthen CAPA tracking and regulatory traceability.
- Built a global knowledge-sharing culture by mentoring internal and external audiences through the community of practice, and designing and delivering training.
- Authored technical reports and policy briefs that informed global and national decision-makers, shaping reforms in good regulatory practices, information and quality management systems, and market surveillance.
U.S. Pharmacopeia (USP)/PQM+
Chief of Party / Deputy Chief of Party / Regulatory Affairs Specialist
05.2018 - 02.2024
Job overview
- Directed USAID-funded PQM+ program ($5.5M), strengthening Pakistan’s pharmaceutical governance, regulatory systems, and lab networks.
- Spearheaded development of Pakistan’s first integrated regulatory information management system, harmonizing licensing, inspections, and PMS functions, including redesign of business processes for digital automation.
- Facilitated adoption of the five IDMP (Identification of Medicinal Products) data standards—integrating both data and process standards—for regulators and industry to strengthen interoperability, data governance, and regulatory decision-making across the medicines lifecycle.
- Advanced national regulator (DRAP) maturity level on WHO GBT from Level I to II, reforming 50+ policies covering GMP, licensing, BE studies, and pharmacovigilance.
- Rolled out bio-equivalence (BE) roadmap and risk-based PMS guidelines; developed and implemented Pakistan’s first national PMS guidance and trained inspectors nationwide.
- Achieved WHO PQ for 5 QC labs and ISO 15189 for 2 public health labs, generating $9M annual cost savings. Established National QC Lab Forum to harmonize standards and sustain donor-funded program gains beyond donor funding. Coordinated recalls and post-marketing quality surveillance between federal and provincial regulators, institutionalizing data-driven decision-making.
- Supported implementation of national AEFI surveillance, aligning with WHO standards and strengthening vaccine safety systems.
- Led development and rollout of the national Antimicrobial consumption digital dashboard to monitor antimicrobial consumption and guide stewardship programs to curb threats of antimicrobial resistance.
- Participated as observer in WHO PQ audits, building national capacity for compliance with global quality standards. Facilitated local Remdesivir production through technology transfer, cutting costs by 50% and serving 80,000+ patients. Led COVID-19 emergency response, including PPE lab establishment, EUA support, and vaccine safety monitoring across 130+ hospitals.
- Represented USP in high-level national committees (National Medicines Policy, International Health Regulations country assessment, GMP, pharmacovigilance, and PIC/S observed audits) and advised the government on regulatory reforms. Supervised and mentored 30+ technical and operations staff, ensuring delivery of high-impact interventions and donor reporting excellence.
Highnoon Laboratories
Senior Manager, Regulatory Affairs
01.2017 - 04.2018
Job overview
- Led regulatory submissions for ASEAN, CIS, and African markets, improving approval success rates by 15%.
- Directed team of 4 officers, streamlining workflows across QA, QC, and R&D to reduce dossier preparation time by 20%.
- Implemented GMP audit and training programs aligned with FDA, PIC/S, and USP standards.
- Developed regulatory information dashboard to track product dossiers and approvals, enhancing compliance monitoring.
World Health Organization
International Consultant (Regulatory Systems)
12.2017 - 12.2017
Job overview
- Advised WHO Tunisia on strengthening regulatory information system frameworks, QMS alignment, and capacity building for medicines inventory management software.
EPOS Health Management
International Consultant (Health Supply Chain)
12.2016 - 01.2017
Job overview
- Led assessment of pharmaceutical supply chain management for Philippines Department of Health.
- Designed roadmap to develop an electronic system to minimize stockouts and improve logistics and distribution of essential medicines.
CCL Pharmaceuticals
Deputy Manager, Regulatory Affairs
01.2016 - 12.2016
Job overview
- Managed preparation of registration dossiers and renewals for international markets.
- Strengthened PV reporting systems and improved compliance with ISO and GMP standards.
World Health Organization
Seconded Consultant to DRAP
08.2015 - 12.2015
Job overview
- Completed NRA self-assessment using WHO GBT; developed Institutional Development Plans for capacity building.
- Designed CTD implementation plan, enabling local industry to align with global regulatory norms.
World Health Organization
International Consultant (Pharmaceutical Sector Assessment)
08.2015 - 09.2015
Job overview
- Led Afghanistan’s WHO Level II Pharmaceutical Sector Assessment survey.
- Produced national report with actionable recommendations for regulatory reform and supply chain resilience.
World Health Organization
National Professional Officer (Essential Medicines & Pharmaceuticals)
01.2006 - 12.2014
Job overview
- Provided technical leadership for WHO’s Essential Medicines & Pharmaceuticals program in Pakistan for nearly a decade, driving reforms in medicines governance, regulatory strengthening, and supply chain resilience, including support to other EMRO countries.
- Supported NRA advancement by guiding WHO GBT self-assessments and institutional development planning; enabled upgrades in GMP, dossier evaluation, and inspections, aligning with international benchmarks.
- Strengthened global quality alignment by supporting WHO PQ readiness, mentoring manufacturers and regulators on dossier preparation, stability studies, and GMP upgrades, and participating as an observer in WHO PQ audits.
- Developed national frameworks including standard treatment guidelines, vaccine vigilance plans, and antimicrobial stewardship programs, improving rational use and patient safety.
- Built supply chain capacity through nationwide trainings on selection and qualification of medicines, quantification and forecasting, procurement, storage and distribution, and rational use. Result: better forecasting accuracy, reduced wastage, and stronger stock management.
- Introduced digital monitoring systems by deploying QUANTIMED and serving as focal person for PAHO’s pharmaceutical inventory database, creating early warnings for stockouts and expiries.
- Monitored utilization of WHO-procured medicines supplied through implementing partners to ensure accountability, equitable distribution, and full benefit from donor-funded resources.
- Led crisis and outbreak response as part of WHO emergency teams, managing essential medicine kits for earthquakes, floods, and IDP settings, and responding to national safety crises (contaminated cardiac drugs, toxic cough syrups). These actions safeguarded patients and strengthened pharmacovigilance and recall systems.
- Advanced disaster resilience through the Safe Hospital program and national disaster-preparedness initiatives in high-risk districts.
- Coordinated donor-funded programs (USAID, DFID, ECHO, AusAID, Global Fund) to sustain medicine supply during emergencies and maintain continuity of care.
- Designed and implemented community mobilization and Participatory Rural Appraisal (PRA) to improve adherence and rational medicine use in diverse communities.
- Supervised WHO staff, pharmacists, and warehouse teams in field operations, embedding WHO standards for procurement, supply chain, and rational use, and building lasting institutional capacity.
Biorex Pharmaceuticals
Regulatory Affairs Assistant
06.2004 - 12.2005
Job overview
- Supported preparation of regulatory dossiers and submissions.
- Maintained compliance records and liaised with national regulators.
Education
Sarhad University of Science & ITIslamabad, Pakistan
Master of Science from Public Health
01.2013
Islamia University of BahawalpurBahawalpur, Pakistan
Bachelor of Science from Pharmacy
01.2004
Certification
- Fellowship in Supply Chain Management, Netherlands
- Fellowship in Infectious Diseases in Humanitarian Emergencies, UK
- Participatory Rural Appraisal (Community Mobilization)
- Lead Auditor Training Course (ISO 13485:2016) – Medical Devices QMS (BSI Training Academy UK)
- Agile/Kanban Project Management, US
- ISO 15189 and ISO 17025 training (Pakistan National Accreditation Council)
- Certified DevResult Contributor (Project M&E)
- WHO training on assessment of the quality part of CTD dossiers (Copenhagen, PQ Team)
- Events Following Immunization (AEFI), Muscat, Oman
- Good Pharmacy Practices, Federation of Asian Pharmaceutical Associations (FAPA), Taiwan
ADDITIONAL INFORMATION
Languages: Arabic, Punjabi, Urdu, English
Timeline
Senior Manager, International Regulatory Policy & Intelligence
U.S. Pharmacopeia (USP)
04.2025 - Current
Senior Technical Advisor & Technical Lead, Regulatory Systems Strengthening
U.S. Pharmacopeia (USP)
03.2024 - 03.2025
Chief of Party / Deputy Chief of Party / Regulatory Affairs Specialist
U.S. Pharmacopeia (USP)/PQM+
05.2018 - 02.2024
International Consultant (Regulatory Systems)
World Health Organization
12.2017 - 12.2017
Senior Manager, Regulatory Affairs
Highnoon Laboratories
01.2017 - 04.2018
International Consultant (Health Supply Chain)
EPOS Health Management
12.2016 - 01.2017
Deputy Manager, Regulatory Affairs
CCL Pharmaceuticals
01.2016 - 12.2016
Seconded Consultant to DRAP
World Health Organization
08.2015 - 12.2015
International Consultant (Pharmaceutical Sector Assessment)
World Health Organization
08.2015 - 09.2015
National Professional Officer (Essential Medicines & Pharmaceuticals)
World Health Organization
01.2006 - 12.2014
Regulatory Affairs Assistant
Biorex Pharmaceuticals
06.2004 - 12.2005
Sarhad University of Science & IT
Master of Science from Public Health
Islamia University of Bahawalpur
Bachelor of Science from Pharmacy