Deborah Cunningham Email & Phone Number
Director of Regulatory Operations @ Vericel® Corporation
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Deborah Cunningham Location
- Boston, MA, US
Deborah Cunningham Work
- 2024 -now Director of Regulatory Operations @
- 2022 -2023 Sr Director, Strategic Operations and Business Excellence, Regulatory, Head @
- 2019 -2022 Director, Commercial Regulatory Submission Management, Head @
- 2017 -2019 Head of CMC Regulatory Submissions @
- 2016 -2017 Director, CMC Regulatory Submissions Process and Innovation Team Lead @
- 2015 -2022 Director CMC Regulatory Submissions Management Team Lead, PDTS @
- 2014 -2016 Director, Pharmaceutical Sciences Regulatory Submissions Lead @
- 2013 -2014 Associate Director, Quality Assurance Site Compliance @
- 2009 -2013 Associate Director, Regulatory Dossier Management, DQA @
- 2006 -2009 Quality Assurance Manager @ Eisai Research Institute
- 1997 -2006 Project Planning Management and Coordination @ Eisai R&D HQ
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
- cGMP
- Pharmaceuticals
- Technology Transfer
- HPLC
- GMP
- Pharmaceutical Industry
- Regulatory Dossier Preparation
- CMC
- Biologics
- Drug Development
- Analytical Chemistry
- Regulatory Submissions
- Quality Assurance
- Regulatory Affairs
- GLP
- Toxicology
- FDA
- Sop
- Validation
- Biotechnology
- Clinical Trials
- Pharmacology
- eCTD
- Clinical Development
- 21 CFR Part 11
- Change Control
- IND
- Regulatory Requirements
- R&D
- Oncology
- Life Sciences
- Quality System
- Biopharmaceuticals
- 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 Biogen, Takeda and Shire. 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 cGMP, Pharmaceuticals, Technology Transfer, HPLC, GMP and more. Deborah Cunningham has 2 emails and 1 mobile phone numbers on RocketReach.
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