Libette Luce Email & Phone Number
Vice President, Head of Regulatory Affairs @ Akero Therapeutics
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Libette Luce Location
- Branchburg, NJ, US
Libette Luce Work
- Vice President, Head of Regulatory Affairs @ (May 2022 - Present)
- Vice President, Head of Regulatory Affairs @ (May 2021 - May 2022)
- Executive Director Global Regulatory Affairs @ (October 2020 - May 2021)
- Senior Director Global Regulatory Affairs @ (September 2017 - October 2020)
- Director Global Regulatory Affairs @ (December 2014 - September 2017)
- Senior Manager US Regulatory Affairs @ (April 2013 - November 2014)
- Senior Manager Global Regulatory Affairs @ (January 2012 - March 2013)
Libette Luce Education
- Seton Hall University
Master of Arts - MA (Diplomacy & International Relations)
- University of Miami
Bachelor of Arts - BA (Political Science and International Studies)
- Dwight-Englewood School
High School Diploma
Libette Luce Skills
- 21 CFR Part 11
- Abbreviated New Drug Application (ANDA)
- Biologics
- Biopharmaceuticals
- Biotechnology
- Business Knowledge
- CMC
- CMC Regulatory Affairs
- CRO
- CRO Management
- Clinical Development
- Clinical Operations
- Clinical Trials
- Common Technical Document (CTD)
- Cross-functional Team Leadership
- Dermatology
- Diabetes
- Drug Development
- EMA
- Endocrinology
- FDA
- GCP
- GMP
- Good Clinical Practice (GCP)
- GxP
- ICH-GCP
- IND
- International Regulations
- MHRA
- Medical Affairs
- NDA
- Neurology
- Oncology
- Pharmaceutical Industry
- Pharmaceutics
- Pharmacovigilance
- Quality Assurance
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Filings
- Regulatory Requirements
- Regulatory Submissions
- SOP
- Standard Operating Procedure (SOP)
- Therapeutic Areas
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Workload Prioritization
- eCTD
- Microsoft Excel
- Microsoft Word
- Regulatory
- Ich Gcp
- Public Speaking
Libette Luce Summary
- Libette Luce, based in Branchburg, NJ, US, is currently a Vice President, Head of Regulatory Affairs at Akero Therapeutics. Libette Luce brings experience from previous roles at Innocoll and Bausch Health Companies Inc.. Libette Luce holds a Master of Arts - MA in Diplomacy & International Relations @ Seton Hall University. With a robust skill set that includes 21 CFR Part 11, Abbreviated New Drug Application (ANDA), Biologics, Biopharmaceuticals, Biotechnology and more. Libette Luce has 2 emails and 2 mobile phone numbers on RocketReach.
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Libette Luce
Vice President, Head of Regulatory Affairs
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