Susan Carino

Principal Consultant, Life Sciences Regulatory Sme @IPM Integrated Project Management Company

San Francisco, CA, US

IPM\'s first employee promoted to the new position of Principal Consultant. Provide project/program/portfolio management business consulting focused on Regulatory Affairs in the Life Sciences Industry. Founding member of IPM’s Quality and Regulatory Affairs Center of Excellence (COE) and IPM’s Product Development Lifecycle Management COE. Leads diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics, medical devices, and in vitro diagnostic tests. Manages projects in all life-cycle stages of product development to ensure high quality and regulatory compliance ranging from research, development, clinical trials, regulatory submissions, health authority information requests, product launches/commercialization, post-approval requirements/commitments, and global expansion. Specializing in streamlining regulatory submission processes, agile project management, and leveraging project management best practices for successfully managing alliance partners. Ensures organizational strategic priorities are visible while leading diverse cross-functional program teams. Delivers complex projects seamlessly by developing detailed integrated project schedules and using the appropriate level of risk/opportunity identification and risk mitigation strategies to ensure quality and regulatory compliance. Holds team members accountable to ensure project objectives and organizational commitments are met.

University of Wisconsin-Madison

MS, Chemistry

UC Berkeley Extension

Project Management, UC Extension Certification

Santa Clara University

MBA, Leadership and Innovation

UCSC Extension

Regulatory Affairs Certification with Honors

UC Berkeley Extension

Instructor for Intro. to Medical Device Regulations and Clinical Trials, Clinical Research: Clinical Trial Phases and Design Course

Oberlin College

BA, Chemistry