Eric J. Lubert, Phd Email & Phone Number

Dr. Lubert is an experienced regulatory professional who has been working in the CRO industry for approximately 18 years. His diverse background in pharmaceutical drug development includes assay development, assay validation, nonclinical toxicology, medical and regulatory writing, regulatory operations, and nearly 15 years of regulatory project management. Dr. Lubert has experience with pre-submission meetings, interactions, and negotiations with the US FDA, which includes submissions across all phases of clinical development. His experience also covers a number of therapeutic areas and indications, including autoimmune disease, cardiovascular, endocrine/metabolic, gene therapy, hematology, immunology, infectious disease, musculoskeletal, neurology/psychology, oncology, otology, and pulmonary/respiratory disease. Dr. Lubert is also proficient in the writing, review, and compilation of documents to support INTERACT, Pre-IND, IND, BLA, and NDA submissions, including meeting request letters, briefing documents, investigator’s brochures, general investigational plans, and quality/nonclinical/clinical summaries.

Listed skills include Toxicology, Glp, Immunology, Biotechnology, and 39 others.