Quality Assurance Regulatory Affairs

PROFESSIONAL SUMMARY

Pharmaceutical quality and regulatory professional with 6+ years of experience spanning R&D, regulatory affairs, and quality assurance. Successfully led WHO Prequalification initiatives for critical anti-TB medications that elevated organizational compliance to international standards. Complemented extensive pharmaceutical industry leadership with a US-earned MPH to develop a comprehensive perspective that integrates quality systems expertise with broader public health implications. Offers a unique combination of international pharmaceutical development experience, global health organization collaboration, and US education in public health systems.

PROFESSIONAL EXPERIENCE

Policy Data Analyst (Capstone Project)

Community of International Neonatal Nurses (COINN), Yardley, PA, USA February 2023 – May 2024

Co-authored manuscript on neonatal mortality outcomes (under review for publication)

Led Quality Improvement Project aligned with WHO guidelines, applying US public health frameworks

Conducted program evaluation and impact assessment

Collaborated with international stakeholders to advocate for evidence-based neonatal care practices

Applied advanced statistical analysis techniques using SAS and other biostatistical methods during MPH coursework and research projects.

Demonstrated expertise in systematic literature reviews, research proposal development, and manuscript preparation leading to refereed publication submissions.

Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and analytical tools including RStudio for data management, visualization, and reporting.

Hands-on experience managing large health datasets, validating data, and conducting epidemiological analyses for policy-relevant research studies.

Knowledgeable in both qualitative and quantitative research methodologies, including survey design, focus groups, and epidemiological modeling.

Practical exposure to health policy research and quality improvement initiatives through collaboration with international health organizations (e.g., WHO).

Research background includes primary care and neonatal health topics, emphasizing digital health surveillance systems and the quality use of medicines.

Developed and implemented open-source analytical resources to enhance healthcare professional decision-making and global health data transparency.

Head RND Global Markets and Regulatory Affairs

DRK Pharma Solutions GmbH, Switzerland January 2020 – January 2023

Led the establishment of DRK Pharma Solutions in Switzerland, a specialized product development company created based on success of the WHO PQ initiative

Built and trained new R&D teams to meet stringent WHO and EU regulatory standards while adapting to diverse client-specific requirements

Developed comprehensive systems for pharmaceutical product development that accommodated varied global regulatory frameworks

Successfully managed transition from internal product development to client-focused pharmaceutical services

Generated approximately $14 million in revenue through implementation of effective R&D systems and processes

Supervised cross-cultural team of 15 scientists ensuring project execution and regulatory compliance

Positioned company as a trusted partner for pharmaceutical development meeting international standards

My background in developing documentation systems following ALCOA+ principles and implementing 21 CFR Part 11 compliance provides me with the expertise needed to serve as a Subject Matter Expert for Change Controls in a regulated biopharmaceutical environment

Head RND Global Markets & Corporate Compliance (GxP)

Remington Pharmaceutical Industries, Lahore, Pakistan April 2017 – January 2020

Created and submitted the first product dossier ever accepted by WHO PQ from Remington, achieving a landmark regulatory milestone through meticulous documentation and persistence

Served as primary liaison with WHO inspectors and assessors, effectively communicating complex technical information and negotiating acceptable solutions

Led cross-functional response teams to address WHO feedback on both dossier submissions and facility inspections

Implemented comprehensive quality management systems (QMS) including root cause analysis, CAPA processes, effectiveness checks, and timeline management

Developed tracking systems to monitor progress across multiple departments, ensuring timely completion of regulatory commitments

documentation to ensure compliance with international standards

Developed and implemented documentation systems following ALCOA and ALCOA+ principles, establishing new data integrity standards

Served as primary liaison with WHO inspectors and assessors, effectively communicating complex technical information

Led cross-functional response teams to address WHO feedback on both dossier submissions and facility inspections

Implemented quality management systems including root cause analysis, CAPA processes, and effectiveness checks

Conducted critical QMS training sessions that elevated company-wide understanding of international compliance requirements

Successfully navigated workplace challenges through effective communication and focus on common organizational goals

Spearheaded the development of Levofloxacin 250 mg anti-TB medication, making Remington the first national company to achieve WHO Prequalification

Company success with WHO PQ under my leadership directly led to the creation of DRK Pharma Solutions to serve international markets

EDUCATION

Master of Public Health (MPH), Epidemiology and Health Analytics

The College of New Jersey, Ewing, NJ 2022-2024 President, Graduate Student Organization (2022-2023)

Doctor of Pharmacy (Pharm.D)

Punjab University College of Pharmacy, Pakistan 2011-2016

Bachelor of Science (BSc)

University of The Punjab, Pakistan 2013-2015

CERTIFICATIONS & PROFESSIONAL DEVELOPMENT

MIT Sloan Artificial Intelligence in Pharma and Biotech (2023)

Health Literacy and Public Health, University at Albany School of Public Health, NY

WHO Prequalification Training Program for Generic Pharmaceutical Products

KEY SKILLS

Regulatory Submission Preparation & Defense

Cross-functional Team Leadership

Quality Management System Implementation

Root Cause Analysis & CAPA Management

Regulatory Communication & Negotiation

WHO Prequalification Process Expertise

Multi-market Product Development

Project Tracking & Timeline Management

Statistical Analysis & Biostatistics (R, RStudio, SPSS)

Systematic Literature Reviews & Evidence Synthesis

Research Proposal Writing & Manuscript Preparation

Health Data Management & Epidemiological Surveillance

Qualitative and Quantitative Research Methods

Policy-Oriented Health Research & Digital Health Analytics

Data Visualization and Reporting (Excel, PowerPoint, R)

Advanced Microsoft Office Suite (Word, Excel, PowerPoint)

Primary Care and Public Health Research Expertise

Global Health Collaboration and Quality Improvement Initiatives

PUBLICATIONS & PRESENTATIONS

Manuscript: "Neonatal Nurses: A Missing Link in Neonatal Mortality Outcomes" (under review)

Presenter at WHO headquarters (Copenhagen) on national pharmaceutical manufacturing standards and WHO PQ implementation

Speaker at ACT Accelerator Facilitation Council Meeting (2022)

Contact this candidate