Shamim Chowdhury

About Shamim Chowdhury

Mr. Chowdhury is a Senior Vice President with the Strategic Compliance Services group of Regulatory and Access (R&A), an independent business unit of Parexel. He has over 25 years of domestic and international experience in pharmaceuticals, biologics and medical device industries. As a Senior Vice President, Mr. Chowdhury serves as a member of the Regulatory Consulting Services Senior Leadership Team and within the global Parexel organization. In his current position, Mr. Chowdhury provides a full range of risk based GMP regulatory consulting services primarily in areas of Product development, Manufacturing, Quality Systems Regulation (QSR), Regulatory Compliance, Regulatory strategy, and Risk Management. He often serves as the Executive Sponsor for large and complex Parexel engagements. Mr. Chowdhury has extensive international travel and work experience with clients in Europe, India, Asia-Pacific, and Puerto Rico.Mr. Chowdhury specializes in developing effective compliance remediation strategy and execution plan for clients facing regulatory enforcement actions, such as Consent Decrees and Warning Letters. He frequently works with client’s Executive Leadership Team, third party law firms and in-house counsel on urgent regulatory compliance matters. His projects have ranged in scope from small start-up and new facility approval to quality system, compliance and remediation support at multi-site, global Pharmaceutical, Medical Devices, Biologics and Pharmacy Compounding firms. Specific activities have included GMP Assessment of Manufacturing Facilities and Quality Systems, Compliance Audits for drug (Sterile and non-sterile) and device manufacturer, mock-PAI, Data Integrity Audits and Training, Quality Systems design and implementation, risk-management, and due-diligence support related to mergers and acquisitions.Selected Expertise- Development, implementation and improvement of quality and regulatory systems- Support and Management of Consent Decree, Warning Letter and 483 Response and Remediation- Audit of GMP, QSR and other regulatory systems, including mock FDA/PAI and Data Integrity Audits and Training- Quality Systems design/re-design/re-engineering- Drug development strategy and regulatory submissions - Global Project/Program Management

Experience

1. Senior Vice President

   Parexel

   Jul 2025 — Present · Chicago, IL, US

Education

• Illinois Institute of Technology

  Bachelor of Science - BS

  1995 — 1999