Mary Smith Email & Phone Number
Regulatory Consultant @ MOMENTUM Consulting LLC
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Mary Smith Location
- California, United States
Mary Smith Work
- Regulatory Consultant @ (February 2025 - Present)
- Quality, Regulatory and Clinical Consulting @ Freelance (January 2024 - Present)
- Vice President Regulatory Affairs, Quality Assurance and Clinical @ (April 2022 - October 2023)
- Vice President, Regulatory Affairs and Quality @ (February 2020 - March 2022)
- Senior Director, Safety, Quality Assurance and Regulatory Affairs @ Advanced Cell Diagnostics - a Bio-Techne Company (June 2018 - January 2020)
Mary Smith Education
- University of California, San Francisco
School of PharmacyCertification (American Course on Drug Development and Regulatory Science)
2010-2012 - Pepperdine Graziadio Business School
MS (Technology Management)
1996-1998 - Purdue University
BS (Pharmacy)
1987-1992
Mary Smith Skills
- 21 CFR Part 11
- Auditing
- Biologics
- Biopharmaceuticals
- Biotechnology
- CAPA
- CMC
- CRO
- Change Control
- Clinical Development
- Clinical Trials
- Combination Products
- Corrective and Preventive Action (CAPA)
- Drug Delivery
- Drug Development
- Drug Discovery
- Due Diligence
- FDA
- GCP
- GLP
- GMP
- GxP
- IND
- ISO 13485
- IVD
- In Vitro Diagnostic Development
- LDT
- Life Sciences
- Lifesciences
- Medical Devices
- Medical device
- Oncology
- Pharmaceutical Industry
- Pharmaceutics
- Quality Assurance
- Quality Auditing
- Quality System
- Regulatory
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Strategy
- Regulatory Submissions
- SOP
- Start-up Consulting
- Strategic Thinking
- Strategy
- Technical Documentation
- Technology Transfer
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- V&V
- Validation
- Verification and Validation (V&V)
- eCTD
Mary Smith Summary
- Mary Smith, based in California, United States, is currently a Regulatory Consultant at MOMENTUM Consulting. Mary Smith brings experience from previous roles at Freelance, Chronus Health, Freenome and Advanced Cell Diagnostics - a Bio-Techne Company. Mary Smith holds a 2010 - 2012 School of PharmacyCertification in American Course on Drug Development and Regulatory Science @ University of California, San Francisco. With a robust skill set that includes 21 CFR Part 11, Auditing, Biologics, Biopharmaceuticals, Biotechnology and more. Mary Smith has 4 emails and 5 mobile phone numbers on RocketReach.
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