Michael MacDougall Email & Phone Number
Director of Regulatory Affairs
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Michael MacDougall Location
- Horseheads, NY, US
Michael MacDougall Work
- 2022 -now Director of Regulatory Affairs @ Zennova LLC
- 2019 -now Regulatory Manager @ Zennova LLC
- 2008 -2019 Manager of Regulatory Affairs @ X-GEN Pharmaceuticals, Inc
- 2005 -2008 Quality Product Manager @ X-GEN Pharmaceuticals, Inc
- 2000 -2005 Process Technicial and Lab Technition and Working through Adecco as a Contract Employee @
- 1995 -2000 chemist @ Cadence Environmental Energy
Michael MacDougall Education
- State University of New York at Oswego
BS (Bio-Chemistry)
1993-1995
Michael MacDougall Skills
- FDA
- Regulatory Affairs
- Sop
- GMP
- Regulatory Submissions
- Pharmaceutical Industry
- Change Control
- Regulatory Requirements
- Quality System
- Quality Assurance
- CAPA
- Technology Transfer
- 21 CFR Part 11
- R&D
- eCTD
- U.S. Food and Drug Administration (FDA)
- Biotechnology
- Abbreviated New Drug Application (ANDA)
- annual report
- adverse events
- cmc
- Prior Approval Supplement
- Cross-functional Team Leadership
- Management
- 21 CFR
- SPL
- Pharmacovigilance
- Life Sciences
- Research
- Product Management
- Pharmaceutics
- Regulatory Documentation
- Document Management
- Document Review
- Regulatory Compliance
- Project Portfolio Management
- Project Support
- Multitasking
- Creative Problem Solving
- Cross Functional Team Building
- Knowledge Sharing
- Regulatory Projects
- Document Creation
- u.s. Food and Drug Administration Fda
- u.s. Food and Drug Administration
Michael MacDougall Summary
- Michael MacDougall, based in Horseheads, NY, US, is currently a Director of Regulatory Affairs at Zennova LLC. Michael MacDougall brings experience from previous roles at Zennova LLC, X-GEN Pharmaceuticals, Inc and Corning Incorporated. Michael MacDougall holds a 1993 - 1995 BS in Bio-Chemistry @ State University of New York at Oswego. With a robust skill set that includes FDA, Regulatory Affairs, Sop, GMP, Regulatory Submissions and more. Michael MacDougall has 1 emails and 1 mobile phone numbers on RocketReach.
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