Daniel Bernier Email & Phone Number
Sr. Director - Global Regulatory Affairs - Pre-Approval @ Eli Lilly and Company
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Daniel Bernier Location
- Chapel Hill, NC, US
Daniel Bernier Work
- 2025 -now Sr. Director - Global Regulatory Affairs - Pre-Approval @ Eli Lilly and Company
- 2024 -2025 Executive Director, Regulatory Affairs @ Eli Lilly and Company
- 2023 -2024 Sr. Director Regulatory Affairs @
- 2021 -2023 Sr. Director, Regulatory Affairs, CMC @ Medicago
- 2019 -2021 Sr. Director, Global Supplier Quality Management @
- 2015 -2019 Director, Biosimilars Regulatory CMC @
- 2014 -2015 Director Quality-Biologics @
- 2012 -2014 VP Regulatory Compliance @ Therapeutic Proteins International, LLC
- 2009 -2012 VP of Regulatory Compliance and Sr. Director Regulatory Compliance and Director Quality Assurnace @ Therapeutic Proteins Inc.
- 2007 -2009 Director of Quality Assurance and Regulatory Affairs @
- 2003 -2007 Director of Quality Assurance and Regulatory Affairs @ Stericon
- 1993 -2003 Director of Quality Control @
Daniel Bernier Education
- Keller Graduate School of Management of DeVry University
Master of Business Administration - MBA
2024 - Keller Graduate School of Management of DeVry University
Master of Business Administration - MBA (Chemistry)
2024 - Illinois Institute of Technology
MS (Analytical Chemistry)
2001 - Northern Illinois University
Bachelor’s Degree (Chemistry)
1993
Daniel Bernier Skills
- Leadership
- Auditing
- Clinical Trials
- 21 CFR
- Good Laboratory Practice Glp
- Verification And Validation V&V
- HPLC
- GMP
- GxP
- Regulatory
- Biotechnology
- Regulatory Affairs
- Change Control
- Life Sciences
- Validation
- Quality Assurance
- Medical Devices
- Corrective And Preventive Action Capa
- Biosimilars
- Strategy
- Compliance
- Regulatory Requirements
- Operations
- Quality System
- Research And Development R&D
- Analytical Chemistry
- CRO Management
- Pharmaceuticals
- Risk Management
- GCP
- Pharmaceutics
- Cross Functional Team Leadership
- Clinical Development
- Manufacturing
- Quality Auditing
- Marketing
- U.S. Food And Drug Administration Fda
- Biologics
- Regulatory Compliance
- Clinical Operations
- Regulatory Submissions
- Management
- Alliance Management
- Project Management
- Standard Operating Procedure Sop
- Quality Control
- Pharmaceutical Industry
- Technology Transfer
- GLP
- CAPA
- Quality Systems
- FDA
- Sop
- 21 CFR Part 11
- Biopharmaceuticals
- u.s. Food and Drug Administration
- Standard Operating Procedure
- Corrective and Preventive Action
- Good Laboratory Practice
- Verification and Validation
- Research and Development
- Start Ups
- Vendor Management
- Communication
- Environmental Compliance
- Equipment Maintenance
Daniel Bernier Summary
- Daniel Bernier, based in Chapel Hill, NC, US, is currently a Sr. Director - Global Regulatory Affairs - Pre-Approval at Eli Lilly and Company. Daniel Bernier brings experience from previous roles at Eli Lilly and Company, POINT Biopharma, Medicago and KBI Biopharma. Daniel Bernier holds a Master of Business Administration - MBA @ Keller Graduate School of Management of DeVry University. With a robust skill set that includes Leadership, Auditing, Clinical Trials, 21 CFR, Good Laboratory Practice Glp and more. Daniel Bernier has 2 emails and 1 mobile phone numbers on RocketReach.
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