Senior Director, CMC Regulatory Affairs

• Apr 2023 - Present

Director, Regulatory Affairs CMC

• Sep 2022 - Apr 2023

Associate Director, Regulatory Affairs CMC

• Sep 2021 - Sep 2022

Senior Manager, Regulatory Affairs CMC

• Sep 2020 - Sep 2021

Manager, Regulatory Affairs CMC

• Mar 2019 - Aug 2020

Senior Associate, Regulatory Affairs CMC

• Jun 2018 - Mar 2019

Assistant Women's Soccer Coach

• Aug 2014 - May 2019

After four years as a member of the Occidental women's soccer team and three years as its starting goalkeeper, Tayler Renshaw '14 has joined the Tigers as an assistant coach. While at Oxy, Renshaw earned the Brine Award of Distinction for her performance on the field, in the classroom and in the community. The team competes in the DIII Southern California Intercollegiate Athletic Conference (SCIAC). After four years as a member of the Occidental women's soccer team and three years as its starting goalkeeper, Tayler Renshaw '14 has joined the Tigers as an assistant coach. While at Oxy, Renshaw earned the Brine Award of Distinction for her performance on the field, in the classroom and in the community. The team competes in the DIII Southern California Intercollegiate Athletic Conference (SCIAC).

CalSouth Competitive Youth Soccer Head Coach & Goalkeeper Coach

• Feb 2017 - Jun 2018

2018-2019: Goalkeeper Coach 2017-2018: Goalkeeper Coach & Head Coach Girls Club 2007 LA Premier FC, 2003 LA Premier FC 2018-2019: Goalkeeper Coach 2017-2018: Goalkeeper Coach & Head Coach Girls Club 2007 LA Premier FC, 2003 LA Premier FC

Regulatory Affairs Specialist I / II

• Jul 2016 - Jun 2018

The Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory affairs activities relating to all City of Hope sponsored INDs, investigator-initiated INDs, and Drug Master Files. This includes assistance with preparation of initial Phase I/II clinical trial IND filings and maintenance of the IND in the setting of an academic research organization. The position assists in the development and implementation of regulatory strategies for interacting with regulatory… Show more The Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory affairs activities relating to all City of Hope sponsored INDs, investigator-initiated INDs, and Drug Master Files. This includes assistance with preparation of initial Phase I/II clinical trial IND filings and maintenance of the IND in the setting of an academic research organization. The position assists in the development and implementation of regulatory strategies for interacting with regulatory agencies and will act as a liaison with the FDA, NIH-OBA, and institutional regulatory committees. This position provides staff expertise and preparatory assistance to Regulatory Affairs management in preparation of documents for regulatory submissions to applicable regulatory agency(ies). This position ensures regulatory affairs compliance of clinical trials under a COH-sponsored IND. Founded in 1913, City of Hope is one of only 45 comprehensive cancer centers in the nation, as designated by the National Cancer Institute. Our role as leaders in patient care, basic and clinical research, and the translation of science into tangible benefit is widely acknowledged. Show less The Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory affairs activities relating to all City of Hope sponsored INDs, investigator-initiated INDs, and Drug Master Files. This includes assistance with preparation of initial Phase I/II clinical trial IND filings and maintenance of the IND in the setting of an academic research organization. The position assists in the development and implementation of regulatory strategies for interacting with regulatory… Show more The Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory affairs activities relating to all City of Hope sponsored INDs, investigator-initiated INDs, and Drug Master Files. This includes assistance with preparation of initial Phase I/II clinical trial IND filings and maintenance of the IND in the setting of an academic research organization. The position assists in the development and implementation of regulatory strategies for interacting with regulatory agencies and will act as a liaison with the FDA, NIH-OBA, and institutional regulatory committees. This position provides staff expertise and preparatory assistance to Regulatory Affairs management in preparation of documents for regulatory submissions to applicable regulatory agency(ies). This position ensures regulatory affairs compliance of clinical trials under a COH-sponsored IND. Founded in 1913, City of Hope is one of only 45 comprehensive cancer centers in the nation, as designated by the National Cancer Institute. Our role as leaders in patient care, basic and clinical research, and the translation of science into tangible benefit is widely acknowledged. Show less

Regulatory Science Contractor

• Aug 2015 - Mar 2017

Continuation of work as Regulatory Science hourly contractor after successful completion of 12 week internship. Contract position includes assisting and writing strategic reviews, US Orphan Drug Designations, Pediatric Review Designations, Breakthrough Designations, Pre-Submission Meeting, EU Orphan Drug Designation, and Quality Control review of both EMA Orphan Drug Designations and other projects.

Regulatory Affairs Intern

• Jun 2015 - Aug 2015

Coté Orphan, LLC, a regulatory affairs advisory firm based in Silver Spring, MD, provides valuable strategic planning and execution services to companies developing or seeking to develop orphan drugs. Under the leadership of Dr. Timothy R. Coté, an orphanology expert and former Food and Drug Administration (FDA) Director for the Office of Orphan Products Development (OOPD), Coté Orphan demystifies the FDA regulatory process. Coté Orphan knows the FDA hurdles unique to orphan products and forges… Show more Coté Orphan, LLC, a regulatory affairs advisory firm based in Silver Spring, MD, provides valuable strategic planning and execution services to companies developing or seeking to develop orphan drugs. Under the leadership of Dr. Timothy R. Coté, an orphanology expert and former Food and Drug Administration (FDA) Director for the Office of Orphan Products Development (OOPD), Coté Orphan demystifies the FDA regulatory process. Coté Orphan knows the FDA hurdles unique to orphan products and forges successful pathways to regulatory success.

Diabetes Prevention Program Lifestyle Coach

• Mar 2015 - Jun 2016

Working with patients from screenings provided by Diabetes Free Riverside through the Claremont Graduate University Community Translational Research Institute. The National Diabetes Prevention Program lifestyle change program is the nation's foremost evidence-based program for the prevention of type 2 diabetes. Trained by an expert Master Trainer from Emory Centers' Diabetes Training and Technical Assistance Center. Facilitating the proven-effective lifestyle change program to patients of the… Show more Working with patients from screenings provided by Diabetes Free Riverside through the Claremont Graduate University Community Translational Research Institute. The National Diabetes Prevention Program lifestyle change program is the nation's foremost evidence-based program for the prevention of type 2 diabetes. Trained by an expert Master Trainer from Emory Centers' Diabetes Training and Technical Assistance Center. Facilitating the proven-effective lifestyle change program to patients of the Riverside and Jurupa Valley communities. Show less Working with patients from screenings provided by Diabetes Free Riverside through the Claremont Graduate University Community Translational Research Institute. The National Diabetes Prevention Program lifestyle change program is the nation's foremost evidence-based program for the prevention of type 2 diabetes. Trained by an expert Master Trainer from Emory Centers' Diabetes Training and Technical Assistance Center. Facilitating the proven-effective lifestyle change program to patients of the… Show more Working with patients from screenings provided by Diabetes Free Riverside through the Claremont Graduate University Community Translational Research Institute. The National Diabetes Prevention Program lifestyle change program is the nation's foremost evidence-based program for the prevention of type 2 diabetes. Trained by an expert Master Trainer from Emory Centers' Diabetes Training and Technical Assistance Center. Facilitating the proven-effective lifestyle change program to patients of the Riverside and Jurupa Valley communities. Show less

Graduate Teaching Assistant

• Aug 2015 - May 2016

Fall 2015: ALS 432 Writing an Orphan Drug Application ALS 398 Premedicine Professional Development Spring 2016: ALS 398 Premedicine Professional Development As a teaching assistant, I assisted professors with grading, office hours, class preparation, scheduling, and general class organization. Fall 2015: ALS 432 Writing an Orphan Drug Application ALS 398 Premedicine Professional Development Spring 2016: ALS 398 Premedicine Professional Development As a teaching assistant, I assisted professors with grading, office hours, class preparation, scheduling, and general class organization.

Student Consultant

• Aug 2015 - May 2016

The capstone of the Keck Graduate Institute Master's of Bioscience (MBS) program is the Team Master's Program (TMP) in which teams of three to six students work with sponsoring companies to solve real problems. I served as the project lead, which included coordinating meetings between the student team, our faculty liaison, and corporate liaison. The capstone of the Keck Graduate Institute Master's of Bioscience (MBS) program is the Team Master's Program (TMP) in which teams of three to six students work with sponsoring companies to solve real problems. I served as the project lead, which included coordinating meetings between the student team, our faculty liaison, and corporate liaison.

Teaching Assistant

• Jan 2014 - May 2014

Biology Department Course: Ecology Assisted with laboratory set up, field trips, data collection, tutoring, etc.

Games Management Event Staff

• Aug 2012 - May 2014

Worked for the Athletics Department on the following sports: Men's Soccer, Men's Basketball, Men's Water Polo, Football, Baseball, Softball, Women's Volleyball, Women's Basketball, Women's Water Polo, Cross Country, Track and Field, Women's Lacrosse, Rugby, and Swimming & Diving. Responsibilities included set up and take down of equipment and facilities, ticketing, video and live stream, audio, book/score keeping and scoreboard operation.

Undergraduate Researcher

• May 2012 - Aug 2013

Summer 2012: 4 weeks participation in fieldwork at La Selva on a tree census for an abundant canopy tree (Pentaclethora macroloba). Collected Microtylopteryx hebardi and performed anatomical analyses and dissections during the following academic year. Also conducted independent project on tropical grasshopper M. hebardi including field observations, feeding experiments, and a photograph/video analyses (using JWatcher). Summer 2012: 4 weeks participation in fieldwork at La Selva on a tree census for an abundant canopy tree (Pentaclethora macroloba). Collected Microtylopteryx hebardi and performed anatomical analyses and dissections during the following academic year. Also conducted independent project on tropical grasshopper M. hebardi including field observations, feeding experiments, and a photograph/video analyses (using JWatcher).