Supriya Singh

About Supriya Singh

A focused, detail-oriented, and accomplished Regulatory Affairs professional with over 9+ years of experience facilitating the effective development and execution of essential clinical research studies across organizations. Possesses in-depth knowledge of rules and regulations, the Regulatory Application process, and research fundamentals. Responsible to work as Regulatory Lead, Regulatory Affairs Consultant, CTA Submission Manager for Clinical trials (Phase1-IV), with experience in various indication, cell and gene therapy and pediatric trials. Successfully managed multiple clinical trials on global level with multiple participating countries, mainly with Europe but also including other countries. In depth knowledge of submission procedures to Competent authorities within EU as well rest of the world countries1) Therapeutic Area: Oncology, Rare Disease, Gene Therapy, Cardiac Indication, Immune System diseases, Congenital, Hereditary, and Neonatal diseases and abnormalities2) IMPs: Chemical, Biological/Biotechnological origin, ATMP Gene therapy (GMO)

Experience

1. Regulatory Affairs Consultant

   Parexel

   Mar 2024 — Present

Education

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

  PG Diploma, O.T technology in association with Asian Heart Research Insitute

• Gurunanak Khalsa College of Arts,Science and Commerce

  Bachelor’s Degree, Biotechnology

• ICFAI University

  MBA in Operations Management

Skills

• Microsoft Excel
• Relationship Building
• Global Regulatory Compliance
• Team Management
• Regulatory Affairs
• Training
• Proficient Computer Literacy
• Clinical
• Teaching
• Informed Consent
• Public Speaking
• Regulatory Submissions
• Leadership
• Clinical Research
• Good Clinical Practice (Gcp)
• Regulatory Guidelines
• Clinical Trial Management System (Ctms)
• Healthcare
• Project Management