Waqas Khan
@waqaskhan1
Experienced Regulatory Affairs Manager with a focus on compliance and strategy.
What I'm looking for
I am a seasoned Regulatory Affairs and Quality Operations Professional with over 15 years of experience in the pharmaceutical industry. My career has been marked by a commitment to regulatory strategy development, dossier submissions, and international business development. I have successfully managed global regulatory submissions and compliance, ensuring product approvals in diverse markets.
In my current role as Senior Regulatory Affairs & Business Development Manager at ZAFA Pharmaceutical, I have formulated regulatory strategies and established effective pre- and post-market regulatory processes. My previous positions have equipped me with a robust understanding of regulatory compliance, risk management, and quality assurance, allowing me to lead teams effectively and achieve significant milestones, such as securing ISO certifications and enhancing product approval efficiency.
Experience
Work history, roles, and key accomplishments
Senior Regulatory Affairs & Business Development Manager
ZAFA Pharmaceutical Laboratories (Pvt.) Ltd
Apr 2023 - Present (2 years 2 months)
Currently managing regulatory strategies and ensuring timely submissions of dossiers for various markets. Overseeing regulatory inspections and compliance initiatives to establish effective pre- and post-market processes.
Regulatory Affairs Advisor & Consultant
Qatar Pharmaceutical Industries Co.
Jan 2021 - Jan 2022 (1 year)
Provided consultancy services achieving ISO certifications and securing GCC manufacturing licenses and safety approvals for the organization.
Manager Regulatory Affairs
ZAFA Pharmaceutical Laboratories (Pvt.) Ltd
Jan 2018 - Feb 2021 (3 years 1 month)
Oversaw CMC activities and regulatory submissions across multiple countries, collaborating with global health authorities to ensure compliance.
Manager Regulatory Affairs & R&D
Royal Group
Jan 2015 - May 2018 (3 years 4 months)
Led dossier preparation and submission for alternative medicines and medical devices, enhancing inspection protocols for audits.
Assistant Manager Regulatory Affairs
INDUS PHARMA (Pvt.) Ltd
Feb 2014 - Jan 2015 (11 months)
Assisted in managing regulatory affairs, ensuring compliance with local and international regulations.
Officer Quality Assurance & Compliance
INDUS PHARMA (Pvt.) Ltd
Jan 2010 - Jan 2011 (1 year)
Managed quality assurance and compliance processes to ensure product safety and regulatory adherence.
Quality Control Analyst – Packaging Material
PFIZER Laboratories
May 2004 - Aug 2005 (1 year 3 months)
Conducted quality control analysis for packaging materials, ensuring compliance with regulatory standards.
Medical Transcriptionist
Bimslink Information & Technology
Feb 2003 - Feb 2004 (1 year)
Performed medical transcription tasks, ensuring accuracy and confidentiality of patient information.
Education
Degrees, certifications, and relevant coursework
University of Karachi
Master of Arts, International Relations and Political Science
2004 - 2014
Completed a Double MA in International Relations and Political Science, gaining insights into global politics, international relations, and policy-making processes.
Preston University
Master of Business Administration, Health Management
2008 - 2010
Completed an MBA in Health Management, focusing on the intersection of healthcare and business practices, equipping with skills necessary for effective management in health-related organizations.
Government Islamia Science College
Bachelor of Science, Microbiology, Biochemistry, Zoology
2000 - 2003
Earned a B.Sc in Microbiology, Biochemistry, and Zoology, providing a strong foundation in biological sciences and laboratory techniques essential for a career in pharmaceuticals.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
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