Lesbeth C. Rodriguez
Director, Regulatory Policy and Science
- Role
- Director, Regulatory Policy and Innovation at Bayer
- Location
- Berkeley, CA, US
- LinkedIn followers
- 500 followers
About Lesbeth C. Rodriguez
Recognized regulatory policy leader specializing in Advanced Therapy Medicinal Products (ATMPs) and Chemistry, Manufacturing, and Controls (CMC) across all modalities. She represented PhRMA in the ICH Q13 Implementation Working Group and currently represents PhRMA in the ICH Cell and Gene Therapy Discussion Group. In addition, she is the Chair of BIO Regenerative Medicine Committee and a member of the ARM US Policy Advisory Group, the ASGCT Regulatory Affairs Committee, and PhRMA\'s Emerging Biotherapeutics, Rare Disease, and NAM Work Groups driving harmonization efforts, regulatory efficiency, and policies that enhance patient access.
Experience
Director, Regulatory Policy and Innovation
Apr 2022 — Present · CA, US
Education
University of Pennsylvania
Biochemistry
Florida Atlantic University
Chemistry
Skills
- 21 Cfr Part 11
- Clinical Development
- Biopharmaceuticals
- Regulatory Affairs
- Lifesciences
- Vaccines
- Pharmaceutical Industry
- Sop
- Fda
- Change Control
- V&V
- Process Simulation
- Gmp
- Manufacturing
- Quality Assurance
- Biotechnology
- Medical Devices
- Capa
- Product Development
- Technology Transfer
- Validation
- Aseptic Processing
- Hplc
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