David Lucking, B.Sc.

David Lucking is currently Senior Director, Regulatory Science, Drugs and Biologics at Voisin Consulting Life Sciences. As both an experienced regulatory scientist and business-oriented manager, David assists clients in the design and implementation of global regulatory strategies as well as with their core technical needs.

David holds 25+ years of experience in the regulatory field and has been a key contact with regulatory agencies for 15+ years. He has significant expertise in preparing detailed technical documents for INDs, ANDAs, NDAs, and MAAs with the FDA and European Regulatory Agencies. He has acquired experience with pre-clinical and clinical trials, interfacing with the FDA and European regulatory agencies, and participating in creating strategic plans relating to developing pharmaceutical projects from concept to FDA approval.

David has extensive experience working with strategic planning & business analysis, new product development & support, business & pharmaceutical partner alliances, venture capital due diligence, clinical trial study design, quality assurance & regulatory affairs, FDA communications, cGMPs, and QC laboratory operations.

David has served as the board member of Accu-Break Pharmaceuticals Inc. and PharmaNet Development Group, Inc.

Prior to VCLS, he held several key management positions involving both technical and business development activities at various pharmaceutical companies. His most recent position was as Vice President of Regulatory Affairs, Quality Assurance and Clinical Research at ProSolos Pharmaceuticals. He was Executive Director of Regulatory Affairs, QA & QC for Hercon Pharmaceuticals, LLC from 2012-2013, Co-Founder, Chief Operating Officer and Vice President of Regulatory Affairs at Accu-Break Pharmaceuticals, Inc. from 2003 to 2012 and Executive Director of Medical & Regulatory Affairs at Noven Pharmaceuticals, Inc. from 1987 to 2003.

From 1983 to 1987, he was employed by Key Pharmaceuticals, Inc. in Miami, Florida where he was responsible for all quality control functions before which he was employed by Cordis Dow Corporation, a manufacturer of artificial kidneys.

David has a Bachelor of Science degree in Biological Science from Florida State University.

He has co-authored an article in the European Journal of Clinical Research. David is based in Cambridge.