Deborah Cunningham Email & Phone Number
Director of Regulatory Operations @ Vericel® Corporation
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Deborah Cunningham Location
- Boston, MA, US
Deborah Cunningham Work
- Director of Regulatory Operations @ (November 2024 - Present)
- Senior Consultant: Strategy to Execution Project Management Leadership @ (April 2024 - August 2024)
- Sr Director, Strategic Operations and Business Excellence, Regulatory, Head @ (March 2022 - September 2023)
- Director, Commercial Regulatory Submission Management, Head @ (January 2019 - March 2022)
- Director CMC Regulatory Submissions Management Team Lead, PDTS @ (March 2015 - March 2022)
- Head of CMC Regulatory Submissions @ (October 2017 - January 2019)
- Director, CMC Regulatory Submissions Process and Innovation Team Lead @ (October 2016 - October 2017)
- Director, Pharmaceutical Sciences Regulatory Submissions Lead @ (July 2014 - October 2016)
- Associate Director, Quality Assurance Site Compliance @ (November 2013 - July 2014)
- Associate Director, Regulatory Dossier Management, DQA @ (October 2009 - October 2013)
- Quality Assurance Manager @ Eisai Research Institute (September 2006 - October 2009)
- Project Planning Management and Coordination @ Eisai R&D HQ (July 1997 - October 2006)
Deborah Cunningham Education
- King's College London
MSc (Quality Control & Pharmaceutical Analysis with minor on PK/ADME and Pharmaceutical Technology)
1992-1993 - University of Costa Rica
BSc (Chemisty-)
1980-1985
Deborah Cunningham Skills
- 21 CFR Part 11
- Analytical Chemistry
- Biologics
- Biopharmaceuticals
- Biotechnology
- CMC
- CMC development
- Career Management
- Change Control
- Change Management
- Clinical Development
- Clinical Trials
- Communication
- Continuous Process Improvement
- Data Analytics
- Drug Development
- FDA
- GLP
- GMP
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- HPLC
- IND
- Leadership
- Life Sciences
- New Drug Application (NDA)
- Oncology
- Organization Skills
- Pharmaceutical Industry
- Pharmaceuticals
- Pharmacology
- Program Management
- Project Management
- Project Planning
- Quality Assurance
- Quality Management
- Quality System
- R&D
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Dossier Preparation
- Regulatory Requirements
- Regulatory Science
- Regulatory Submissions
- SOP
- Standard Operating Procedure (SOP)
- Strategic Planning
- Strategic Thinking
- Strategic Transformation
- Submission management
- Technology Transfer
- Timeline Management
- Toxicology
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- Validation
- Veeva Vault
- cGMP
- eCTD
- Good Laboratory Practice Glp
- Regulatory
- Materials
- Oversight
- Compliance
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Latin America
- Submissions
- Standard Operating Procedure
- Good Laboratory Practice
- u.s. Food and Drug Administration
Deborah Cunningham Summary
- Deborah Cunningham, based in Boston, MA, US, is currently a Director of Regulatory Operations at Vericel® Corporation. Deborah Cunningham brings experience from previous roles at IPM Integrated Project Management Company, Biogen, Takeda and Shire Pharmaceuticals. Deborah Cunningham holds a 1992 - 1993 MSc in Quality Control & Pharmaceutical Analysis with minor on PK/ADME and Pharmaceutical Technology @ King's College London. With a robust skill set that includes 21 CFR Part 11, Analytical Chemistry, Biologics, Biopharmaceuticals, Biotechnology and more. Deborah Cunningham has 2 emails and 1 mobile phone numbers on RocketReach.
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