Elijah Tan

Mr. Tan has over 25 years of experience in the biotechnology/pharmaceutical industry, with close to 2 decades of biologics and biopharmaceutical CMC regulatory experience. Since starting his consulting career in 2017, Mr. Tan has advised numerous cell and gene therapy, biosimilar, and novel biologic clients on a wide range of CMC topics and provided services such as regulatory strategy consultations, global submissions, health authority interactions, and CMC gap assessments. He has spearheaded regulatory strategies, significantly contributed to 9 BLA and 2 EU MAA approvals, and supported more than 40 investigational biological products, including monoclonal antibodies, bi- and tri-specifics, gene-edited autologous therapies, mRNA/lipid nanoparticle products, oncolytic viruses, and antibody-drug conjugates across different stages of clinical development. Before consulting, Mr. Tan held senior leadership positions in regulatory affairs at Coherus Biosciences, Genentech/Roche, and Biogen, where he was responsible for global CMC regulatory strategies, health authority negotiations, and successful product approvals. He also has hands-on experience in pharmaceutical development, analytical chemistry, quality assurance, regulatory compliance, and quality systems implementation from his earlier career at Vertex Pharmaceuticals and Merck. Mr. Tan is US-RAC and EU-RAC certified and holds an M.S. in Pharmaceutical Quality Assurance/Regulatory Affairs from Temple University and a B.S. in Chemistry from West Chester University.