Mary L. Waters

eCTD Publishing Services
How Can I Help You?

As a Senior Consultant for HartmannWillner, Mary can provide you with technical advice and expertise in:

  • Electronic Common Technical Documents (eCTD) publishing services
  • ICH and FDA regulatory requirements
  • Associated tools and technologies for producing eCTD regulatory affairs compliant submissions

Mary has over 19 years of experience in regulatory affairs, clinical research, drug development, and manufacturing. She also has an Electronic Submission Gateway (ESG) and an electronic Medical Device Reporting (eMDR) 3500A account with the FDA.

THOUGHT LEADERSHIP

FDA Will Not Delay the
Implementation of the eCTD
DMF Mandate Again

At the DIA Regulatory, Submission and Information
Management (RSIDM) conference held in Bethesda, MD,
February 2018, the FDA directly stated that they
would not delay the implementation of the eCTD DMF
mandate again.
Read Post

Frequently Asked Questions

How many years of experience do you have?

Mary has over 19 years of experience in regulatory affairs, clinical research, drug development, manufacturing, and publishing eCTD submissions.

What are your areas of expertise?

Mary prepares eCTD Regulatory Affairs documents for submission in accordance with FDA regulations and guidelines:

  • Investigational New Drug (IND) application
  • New Drug Application (NDA)
  • Biologics License Application (BLA)
  • Pre-marketing Application (PMA)
  • Amendments and supplements
What professional experience do you have?

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.

Mary also 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.

What were your main responsibilities in the positions you held?

In her most recent position at HHS/OS/ASPR/BARDA, Mary functioned as the Records Management (RM) Liaison Subject Matter Expert (SME) responsible for:

  • Organizing, tracking, maintaining, and archiving all regulatory, quality, and program records.
  • Managing all of BARDA’s standard operating procedures (SOPs)
  • Administrator for the BARDA SOP Training Program
In what other areas do you have certifications?

Mary earned her Lean Six Sigma – Yellow Belt Certification from DHHS.

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