Carol M Waldo

Regulatory Affairs Consultant

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Location:

Lexington, MA

Industry:

Pharmaceuticals

Work:

Regulatory Affairs Consultant
Spero Therapeutics Nov 2016 - Feb 2019
Head of Regulatory Affairs
Contrafect Corp May 2016 - Aug 2016
Vice President Regulatory Affairs
Merck Feb 2015 - Sep 2015
Executive Director, Infectious Disease
Cubist Pharmaceuticals Sep 2014 - Jan 2015
Vice President Regulatory Affairs

Education:

Boston University 2018
North Central College
Bachelors, Bachelor of Arts, Chemistry Ucla Fielding School of Public Health

Skills:

Regulatory Submissions
Ind
Regulatory Affairs
Pharmaceutical Industry
Clinical Development
Drug Development
Biologics
Fda
Biotechnology
Oncology
Clinical Trials
Small Molecules
Clinical Research
Gcp
Regulatory Requirements
Biopharmaceuticals
Medical Affairs
Quality Assurance
Cross Functional Team Leadership
U.s. Food and Drug Administration
Global Regulatory Strategy
Meetings and Interactions With Regulatory Agencies
Regulatory Support To Due Diligence Activities
Pediatric Development
Technology Transfer
Gmp
Global Drug Development
Glp
Quality Auditing
Nda
Regulatory Strategy Development
Ich Gcp
Sop
Protocol
Cmc
Dermatology
Validation
Cro
Clinical Study Design
Good Clinical Practice
Standard Operating Procedure

Certifications:

License Us, Canada, and Eu Rac Certifications
Regulatory Affairs Certification
Rac-Canada
Rac-Eu
Rac-Us
Regulatory Affairs Professional Society (Raps), License Us, Canada, and Eu Rac Certifications

Carol Waldo

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