Sterling Chung

About Sterling Chung

Driven pharmaceutical executive offering 20+ years of experience leading strategies in clinical and CMC regulatory affairs, product development, and regulatory intelligence in the US, Canada, EU, and Japan. Known as an expert in creating operational efficiencies and leading global regulatory filings. Motivated, innovative, and collaborative with a proven track record of successful negotiations and maintaining high-quality relationships with regulatory agencies. Highly praised for problem-solving and communication skills, regulatory submissions, and coaching cross-functional teams.

Experience

1. Chief Regulatory & Quality Officer

   Aurion Biotech

   Apr 2025 — Present

   Worked with FDA (CBER and CDER), Office of Combination Products (OCP) and Health Canada (BRDD) on a combination therapy of cells and small molecule in ophthalmology. Led pre-IND meeting with CDER and CBER for an ophthalmology combination product (AURN001) on 8 November 2022. IND opened on 14 April 2023. Led Type C meeting with CDER and CBER on 16 July 2024 Led pre-CTA meeting with Health Canada BRDD on 23 October 2023. No Objection Letter on 15 December 2023. Submitted and received Breakthrough (BT) and Regenerative Medicine Advanced Therapy (RMAT) Designations Led Type B meeting (initial kickoff meeting for BTD and RMAT) with CBER and CDER on 30 October 2024 Assumed Quality (QA, QC, and PQL) function and revamped the structure, oversight and direction for a combination cell therapy product that had a shelf-life of 48 hours in July 2024 Mentored, guided, and trained direct reports and cross functional team members Hired multiple direct reports and managing 10+ different vendors to support various Regulatory, Nonclinical, Medical Writing, and Quality Assurance

Education

• Purdue University

  Certificate, Regulatory and Quality Assurance Certificate

  2006 — 2007

• University of Michigan

  Bachelors of Arts and Science, Biology and Political Science Major

  1999 — 2003

Skills

• Nda
• Clinical Research
• Drug Development
• Gcp
• Pharmaceutical Industry
• Fda
• Ectd
• Regulatory Submissions
• Oncology
• Protocol
• Strategy
• Clinical Trials
• Regulatory Requirements
• Ind
• Regulatory Strategy
• Regulatory Affairs
• Cmc Regulatory Affairs
• Clinical Development
• Pharmaceutics
• Cmc
• Ctms
• 21 Cfr Part 11
• Regulations