Elaine Ogunbiyi Email & Phone Number
Director, Global Regulatory Operations @ NDA Group AB
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Elaine Ogunbiyi Location
- Gwynedd, PA, US
Elaine Ogunbiyi Work
- 2021 -now Director, Global Regulatory Operations @
- 2020 -2021 Senior Consultant and Submission Director, US @
- 2020 -2020 Independent Regulatory Management Consultant @ Udorattars LLC
- 2019 -2019 Director, Regulatory Affairs Operations and Labeling @
- 2015 -2019 Director, Regulatory Affairs Operations and Labeling @
- 2012 -2015 Director, Regulatory Affairs Operations and Labeling @ CorePharma, LLC
- 2008 -2012 Associate Director, Regulatory Affairs Operations @
- 2004 -2008 Senior Manager, Regulatory Affairs Operations @
- 2000 -2004 Consultant, Regulatory Affairs @ Independent Consulting
- 1998 -2000 Senior Manager, Regulatory Affairs Operations, @ Nycomed Amersham
- 1998 -1999 Regulatory Affairs Operations, Manager @
- 1990 -1998 Regulatory Affairs Manager, Operations @ Eastman Pharmaceuticals
- 1988 -1990 Regulatory Affairs Technical Coordinator @ Eastman Pharmaceuticals
- 1982 -1987 Technical Coordinator @
Elaine Ogunbiyi Education
- San Jose State University
Bachelor of Arts (B.A.) (Chemistry (Biochemistry))
1977-1981 - De Anza College
Associate of Science - AS (Biology/Biological Sciences, General)
1975-1977 - Excelsior High School
High School Diploma (Physical Sciences)
1970-1975
Elaine Ogunbiyi Skills
- Regulatory Affairs
- U.S. Food and Drug Administration (FDA)
- GMP
- Pharmaceutical Industry
- Validation
- Standard Operating Procedure (SOP)
- Corrective and Preventive Action (CAPA)
- Quality System
- Medical Devices
- Regulatory Requirements
- Electronic Common Technical Document (eCTD)
- Quality Assurance
- Change Control
- Cross-functional Team Leadership
- Technology Transfer
- Regulatory Submissions
- Good Laboratory Practice (GLP)
- labeling
- product labeling
- Structure product labeling
- Management
- FDA
- Strategy
- Marketing
- Microsoft Office
- Research
- Customer Service
- Customs Regulations
- Operations Management
- PMA
- CE marking
- Warehousing
- Good Laboratory Practice Glp
- eCTD
- Biotechnology
- Corrective And Preventive Action Capa
- V&V
- Pharmaceutics
- Cross Functional Team Leadership
- Spl
- U.S. Food And Drug Administration Fda
- Electronic Common Technical Document Ectd
- Standard Operating Procedure Sop
- CAPA
- Structure Product
- ISO 13485
- u.s. Food and Drug Administration
- Standard Operating Procedure
- Corrective and Preventive Action
- Electronic Common Technical Document
- Good Laboratory Practice
- Structure Product Labeling
Elaine Ogunbiyi Summary
- Elaine Ogunbiyi, based in Gwynedd, PA, US, is currently a Director, Global Regulatory Operations at NDA Group AB. Elaine Ogunbiyi brings experience from previous roles at NDA Group AB, Udorattars LLC, Amneal Pharmaceuticals and Impax Laboratories. Elaine Ogunbiyi holds a 1977 - 1981 Bachelor of Arts (B.A.) in Chemistry (Biochemistry) @ San Jose State University. With a robust skill set that includes Regulatory Affairs, U.S. Food and Drug Administration (FDA), GMP, Pharmaceutical Industry, Validation and more. Elaine Ogunbiyi has 2 emails on RocketReach.
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