Imran Khan

About Imran Khan

Over 8+ years of global quality assurance/ regulatory affairs experience in the Pharmaceutical Industry. Knowledge of Drug development through commercialization, electronic submissions IND and NDA, ANDA, 510(K), PMA (Pre-Market Approval) regulations to FDA, CTA & MAA submissions to EMA. My technical expertise covers many areas of product/process development, validation, and quality assurance including – life cycle management of products and processes, root cause analysis, formulating corrective and preventive actions, change control management, technology transfer, equipment qualification, validation of cleaning, and manufacturing processes. I am also proficient in analyzing, evaluating, trending, reporting quality, technical data, and regulatory submission documentation. I can work independently or in a team on projects of any magnitude or complexity. I can lead teams and collaborate with multi-functional teams in planning and managing projects. I am actively seeking Full-Time opportunities in the Regulatory Affairs/Quality Assurance Department in the United States. Key Skills: Regulatory Affairs Quality Assurance Validation ( Cleaning Validation; Process Validation; Technology Transfer ) and Qualification Incident and Deviation Handling Root Cause Analysis Change Control Risk Assessment Gap Analysis Audits and Inspections Quality Risk Management Training

Experience

1. Qa Associate, Compliance Qa Supervisor

   Granules Pharmaceuticals, Inc.

   May 2025 — Present · Chantilly, VA, US

Education

• Northeastern University

  MS In Regulatory Affairs

• Deccan School Of Pharmacy

  Bachelor of Pharmacy (B.Pharm.)