Lee Bennett
Gaithersburg,MD
Summary
Regulatory Senior Director driving strategy and delivery with proven results within Pharmaceutical industry. Manages complex program issues while meeting business objectives. Strong collaboration skills and solid experience leading individuals, teams and projects. Collaborates with management teams and stakeholders to uphold company vision.
Overview
30
30
years of professional experience
Work History
Senior Director, Global Regulatory Affairs
AstraZeneca Pharmaceuticals
Gaithersburg, MD
05.2023 - Current
- Lead teams and projects within Respiratory therapy area in regulatory strategy delivering Phase 2/3 trials, NDAs, label extensions and pediatric strategies
Director of Regulatory Affairs (GRAPSQA)
AstraZeneca Pharmaceuticals
Gaithersburg, MD
11.2018 - 04.2023
- Lead regulatory strategy for P3/Launch projects in Respiratory Therapeutic Area successfully delivering agency meetings, NDA preparations and submissions, regulatory defense.
- Deliver strategy for US, EU, CN and International markets
Associate Regulatory Project Director (GRAPSQA)
AstraZeneca Pharmaceuticals
Gaithersburg, MD
01.2017 - 10.2018
- Manage projects in Respiratory Therapeutic Area leading and delivering clinical and marketing application submission planning activities for US, EU, JP, CN and international markets
- Regulatory Affairs Director Pilot program (30%) Apr 2017 - Oct 2018
Associate Director/Group Manager Regulatory Affairs (GRAPSQA, secondee)
AstraZeneca Pharmaceuticals
Manchester UK
07.2014 - 01.2017
- Line manage and regulatory project management
Regulatory Affairs Manager (GRAPSQA, secondee)
AstraZeneca Pharmaceuticals
Manchester UK
12.2013 - 07.2014
- Regulatory project manager for approved products in international markets
Analytical Science Team Manager (PhDev)
AstraZeneca Pharmaceuticals
Manchester UK
04.2011 - 11.2013
- Line manage team of analytical scientists
- Project manage development for launch CMC programs in analytical science (analytical development, validation, stability, tech-transfer
- Lead CMC strategy and deliver Module 3 documents for development and marketing applications
Team Manager, Analytical Science (PhDev)
AstraZeneca Pharmaceuticals
Wilmington, DE
10.2009 - 04.2011
- Line manage and project manage development for launch CMC programs in analytical science
- Manage teams and project in site exit
- Transfer projects from US to UK teams
Senior Scientist I/II (PhDev)
AstraZeneca Pharmaceuticals
Wilmington, DE
08.2000 - 10.2009
- Sr Scientist Aug 2000-2004
- Sr Scientist II 2004-Sep 2009
- Manage projects and tasks for development programs in Analytical Science
Graduate Research and Teaching Assistant
Florida State University
08.1994 - 08.2000
- PhD., Analytical Chemistry
Education
MBA -
07.2009
Ph.D. - Analytical Chemistry
12.2000
BS - Chemistry
06.1994
Skills
- Regulatory marketing and clinical strategies and submissions
- Project management and leadership
- Label extensions, CMC variations, HA queries
- Line Management (constructive conversations, setting objectives, performance management)
- CMC drug development
- Six Sigma
- Team and project strategy and goal setting and attainment
- Project Planning
- Teamwork and Collaboration
- Decision-Making
- Creativity and Innovation
Personal Information
Title: Senior Director, Regulatory Affairs
Timeline
Senior Director, Global Regulatory Affairs - AstraZeneca Pharmaceuticals
05.2023 - Current
Director of Regulatory Affairs (GRAPSQA) - AstraZeneca Pharmaceuticals
11.2018 - 04.2023
Associate Regulatory Project Director (GRAPSQA) - AstraZeneca Pharmaceuticals
01.2017 - 10.2018
Associate Director/Group Manager Regulatory Affairs (GRAPSQA, secondee) - AstraZeneca Pharmaceuticals
07.2014 - 01.2017
Regulatory Affairs Manager (GRAPSQA, secondee) - AstraZeneca Pharmaceuticals
12.2013 - 07.2014
Analytical Science Team Manager (PhDev) - AstraZeneca Pharmaceuticals
04.2011 - 11.2013
Team Manager, Analytical Science (PhDev) - AstraZeneca Pharmaceuticals
10.2009 - 04.2011
Senior Scientist I/II (PhDev) - AstraZeneca Pharmaceuticals
08.2000 - 10.2009
Graduate Research and Teaching Assistant - Florida State University
08.1994 - 08.2000
Wilmington University - MBA,
Florida State University - Ph.D., Analytical Chemistry
Valdosta State University - BS, Chemistry