Tahseen Mirza

About Tahseen Mirza

Fifteen years of FDA experience in senior leadership positions managing Divisions and…

Experience

1. Associate Director for Regulatory Affairs

   FDA

   Jul 2010 — Present

   CDER/OTS/Office of Study Integrity and Surveillance (OSIS) 2016 - Present Responsible for the formulation of policies, guidance and regulation to ensure data supporting regulatory decisions are reliable by conducting and directing inspections of bioavailability/bioequivalence (BA/BE) and nonclinical (GLP) studies submitted to FDA, and Advising strategies to improve inspection planning, execution, evaluation, and provide recommendations to CDER review divisions, while focusing on human subject safety and data integrity. Deputy Director, CDRH Office of Surveillance and Biometrics (OSB) 20••••16 Which leads the knowledge and post market safety signal management efforts for CDRH by providing: Statistical and epidemiological expertise and analysis of clinical data to evaluate safety and effectiveness for premarket evaluation and post market surveillance Timely evaluation of adverse events for signal identification and ongoing surveillance, as well as support for compliance, premarket evaluation, and other CDRH programs Development and implementation of the Center’s data standards and data management strategy, including the Unique Device Identification (UDI) system Leads the Center-wide program for timely and effective evaluation and management of significant safety signals that are in the market Division Director, CDER Office of Compliance/ 20••••14 Office of Manufacturing Product and Quality/Division of Policy, Collaboration and Data Operation Led Division responsible for the management of Field Alert Reporting System, Incidents (cases in which risk to the public health is unknown), Compliance Policy/Guidance development, MedWatch Quality complaints and Drug Quality Sampling program. Deputy Division Director, CDER/OPS/OTR/Division of Product Quality Research (DPQR) 20••••12 Operationally responsible for personnel, equipment and projects involved in research supporting regulatory science

Education

• Youngstown State University

  M.S., M.B.A., Chemistry, Marketing

  1984 — 1988

• Aligarh Muslim University

  M.Sc., Zoology

  1980 — 1982

• Osmania University

  Bachelor of Science (BSc), Biology, Chemistry

  1977 — 1980

• The Hyderabad Public School Ramanthapur - HPS (R)

  High School Diploma, Biology Physics Chemistry

• University of Cincinnati

  Ph.D., Pharmaceutical Sciences

  1992 — 1997

Skills

• Glp
• Oncology
• Dissolution
• Biotechnology
• Regulatory Affairs
• Formulation
• Medical Devices
• Research and Development (R&D)
• Quality Control
• Drug Discovery
• R&D
• Science
• Molecular Biology
• Clinical Development
• Gmp
• Pharmaceutical Industry
• Clinical Research
• Laboratory
• Fda
• V&V
• Hplc
• Chemistry
• Analytical Chemistry
• Validation
• Sop
• Biopharmaceuticals
• Technology Transfer
• Drug Development
• Clinical Trials
• Regulatory Submissions
• CRO
• Pharmaceutics