Principal Regulatory Writer
Certara Drug Development Solutions
As a Principal Regulatory Writer, Dr. Waterland has extensive medical writing experience in the authoring, reviewing, and editing of pre- and post-approval regulatory documents for submission to Global Health Authorities; his primary specialty is authoring and reviewing of submission level Chemistry, Manufacturing, and Controls (CMC) documents for monoclonal antibody biologic drugs, vaccines, CAR-T gene therapy, and other large molecule products.
In addition, he has more than 25 years of industrial research experience in the following scientific areas: Computer Simulation of Molecules and Macromolecules; Data Science including Data Capture, Data Analytics and Data Presentation; Computational Toxicology, including Absorption, Distribution, Metabolism, and Excretion (ADME), Quantitative Structure-Activity Relationship (QSAR) and Physiologically Based Pharmacokinetic (PBPK) modeling; and Risk Assessments. Dr. Waterland has published extensively in the peer-reviewed scientific literature, and has broad experience in the authoring and reviewing of documents for submission to US and European chemical regulatory authorities. He has served on expert panels and was an expert reviewer of several international assessment reports.
Dr. Waterland is Six Sigma Green Belt certified.
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Solutions Circle: eCTD Module 3, How Much Detail Do I Submit?
Wednesday, October 4, 2023
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