Robert Guillemette
Associate Director Regulatory Affairs @ Deciphera Pharmaceuticals
About
A Regulatory Affairs, Operations, and Project Management expert bringing an experienced, innovative, resourceful, and thoughtful approach with a focus on streamlining processes and promoting collaborative, proactive team environments. Recent projects demonstrate a history of successful BLAs, NDAs, and INDs concurrent to qualified end-to-end validated systems implementation. I work to bring a contagious energy and focus supporting and promoting a positive and efficient work environment in an ever-evolving and fast-paced industry.
United States
Stoneham
Biotechnology
Regulatory Development, Regulated Industry, Regulatory Operations, Clinical Affairs, Regulatory Requirements, Resiliency, Creativity and Innovation, Clinical Development, Product Management, Strategic Thinking, Regulatory Agencies, Pharmaceutical process development, Good Clinical Practice (GCP), Annual Reports, Regulatory Strategy, Leadership, Investigational New Drug Application (IND), Skilled Multi-tasker, Product Development, Problem Solving
Experience
Associate Director Regulatory Affairs
Deciphera Pharmaceuticals
Waltham, Massachusetts, United States
Senior Manager Regulatory Affairs
AVEO Oncology
Boston, Massachusetts, United States
Regulatory Affairs Manager
Boston Biomedical, Inc.
Cambridge, MA
Consultant II, Regulatory Operations
Halloran Consulting Group, Inc., a PLG Company
Greater Boston Area
Senior Project Manager, Regulatory Operations and Compliance
bluebird bio
Cambridge, MA
Regulatory Operations
Agios Pharmaceuticals
Cambridge, MA
Manager, Regulatory
Berg LLC
Framingham, MA
Regulatory Affairs Project Manager
Ocular Therapeutix, Inc.
Bedford, MA
Regulatory Affairs Manager
Merrimack
Kendall Square, Cambridge, MA
Senior Regulatory Affairs Associate
Merrimack
Kendall Square - Cambridge, MA
Regulatory Documentation Specialist
Merrimack
Kendall Square, Cambridge, MA
eSubmission Publishing and Submission Process Specialist
Takeda Oncology
Cambridge, MA
Education
Saint Anselm College
Biology
Boston Architectural College
Design Studies-Architectural Technologies
Harvard University
Psychology
Summer course in Psychology leading into Senior Year of High School.
Southern New Hampshire University
General Studies: STEM Concentration
Robert Guillemette's Contact Information
Phone
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