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Mary L. Waters – eCTD Publishing Services

Mary Waters is a Senior Consultant for HartmannWillner, providing technical advice and expertise in electronic Common Technical Documents (eCTD) publishing services, ICH and FDA regulatory requirements, and the associated tools and technologies for producing eCTD regulatory affairs compliant submissions.  Mary has an Electronic Submission Gateway (ESG) as well as an electronic Medical Device Reporting (eMDR) 3500A account with the FDA.  Mary has over 19 years of experience in regulatory affairs, clinical research, drug development, and manufacturing.

Mary’s experience encompasses positions held at the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), U.S. Army Medical Research Materiel Command (USAMRMC), U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Joint Program Executive Office – Chemical and Biological Medical Systems (JPEO-CBMS), pharmaceutical industry, and in consulting environments.

In her most recent position at HHS/OS/ASPR/BARDA, Mary functioned as their Records Management (RM) Liaison Subject Matter Expert (SME) where she organized, tracked, maintained, and archived all regulatory, quality, and program records.  Additionally, she was responsible for managing all of BARDA’s standard operating procedures (SOPs) and was the administrator for the BARDA SOP Training Program.

In previous positions, she managed the eCTD publishing services and structured product labeling (SPL) software to coordinate and prepare CTD Regulatory Affairs documents for submission in accordance with FDA regulations and guidelines:  Investigational new drug (IND), new drug application (NDA), biologics license application (BLA), and pre-marketing application (PMA).

Mary previously served as a Resource and Working Group Member for the ASPR’s SOP Working Group; DOD MRMC/USAMMDA MeRITS Initial Requirements Working Group, SOP Template Working Group, and Protocol Template Working Group.

She earned her Lean Six Sigma – Yellow Belt Certification from DHHS

Email me at: mlwaters@hw-fda.com