Elizabeth Ernst
Global Executive Director of Regulatory for American Regent, Inc.
- Role
- Global Executive Director of Regulatory for American Regent at American Regent, Inc.
- Location
- Columbus, OH, US
- LinkedIn followers
- 500 followers
About Elizabeth Ernst
A highly regarded global regulatory, quality, and compliance leader, and subject matter expert specializing in pharmaceuticals (human and animal), medical devices, EPA, nutraceuticals, OTC and cosmetic products. Can provide guidance, expertise, and hands on experience in the creation of US & international regulatory, medical and distribution strategies for the development and filings of new NDAs, 505b2, ANDAs, 510Ks, EPA registrations, nutraceuticals, OTC an cosmetic products. Have developed and lead successful regulatory and quality teams within the Industry. Proactively interpreting changes in regulations in pharmaceutical development, life cycle management and distribution of product throughout the supply chain. Have demonstrated a successful track record for providing strategic planning, internal & external customer relations, and the ability to get the job done in order to move projects from conception, development, filing, approval, launch, distribution and life cycle management. Experience with FDA, EPA, DEA, OSHA, USDA and AAFCO regulatory products. Understand what is required from a federal and state regulatory status for approving and distributing products to customers.
Experience
Global Executive Director of Regulatory for American Regent
Nov 2019 — Present
Education
Temple University
Master of Science (MS), Master Degree in Quality and Regulatory Affairs.
2011 — 2013
University of Cincinnati College of Pharmacy
Post Granduate Work, Epidemilogy
1993 — 1994
Wright State University
BSN, Nursing
1981 — 1986
Skills
- Medical Affairs
- Business Strategy
- Anda
- Vaccines
- Lifecycle
- Medical Writing
- Regulatory Affairs Submissions Andas and Ndas
- Validation
- Project Management
- Biotechnology
- Nda
- Pharmacovigilance
- Gmp
- Fda Experience
- Regulatory Strategies
- Strategy
- Infectious Diseases
- Pharmaceutics
- Regulatory Affairs
- Clinical Trial Management
- Regulatory Submissions
- Leadership
- Strategic Leadership
- Clinical Trials
- Regulatory Filings
- Pharmaceutical Industry
- Sop
- Fda
- Drug Safety
- Clinical Monitoring
- Regulatory Guidelines
- Oncology
- Protocol
- 21 Cfr Part 11
- Drug Development
- Regulations
- Biopharmaceuticals
- Clinical Development
- Edc
- Therapeutic Areas
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