Mary Todas
Retired
- Role
- Director Technical Development and Regulatory Affairs at Pfizer
- Location
- Kalamazoo, MI, US
- LinkedIn followers
- 500 followers
About Mary Todas
Skills: technical writing, GMP, ICH, 21CFR Chapter 11, eCTD formatting, electronic submissions to FDA, EDQM and European agencies, project management, Microsoft office programs, Documentum (Enterprise Content) programs, Salesforce, LIMS, CitrixExperience negotiating with agencies worldwide in response to questions on registrations, both in writing and over the phone. Managed a small (2-5) person regulatory group; setting priorities, timeframes, reviewing content and training in systems.
Experience
Director Technical Development and Regulatory Affairs
Feb 2019 — Present · Kalamazoo, MI, US
Education
University of Wisconsin-Madison
Bachelor of Science (BS), bacteriology
1979 — 1983
Skills
- Pharmaceutical Industry
- Fda
- Electronic Submissions
- U.s. Food and Drug Administration (Fda)
- Formulation
- Regulatory Requirements
- Regulatory Affairs
- Drug Development
- Technology Transfer
- Validation
- Medical Devices
- Cmc
- Pharmaceutical Manufacturing
- Technical Documentation
- Glp
- Gmp
- Regulatory Submissions
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