Martin Lessem Email & Phone Number
Principal Consultant @ Opus Regulatory Inc.
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Martin Lessem Location
- Massachusetts, United States
Martin Lessem Work
- 2022 -now Principal Consultant @
- 2016 -2022 Principal Consultant and Founder @
- 2016 -2016 Sr. Director, Regulatory Affairs @
- 2014 -2016 Director, Regulatory Affairs - Area and Affiliate @
- 2014 -2014 Consultant @
- 2013 -2014 Consultant @ Boston BioBridges
- 2011 -2013 Director, Regulatory Affairs @ Shire HGT
- 2010 -2011 Director, Alliance US Regulatory and US Agent @
- 2008 -2010 Manager, Regulatory Affairs @
- 2005 -2005 Regulatory Operations @
Martin Lessem Education
- University of Illinois Springfield
Master of Arts - MA (Political Science and Government)
2020-2025 - Rider University
B.A. (Political Science)
2020-2025 - Widener University School of Law
JD (Law)
Martin Lessem Skills
- Regulatory Affairs
- FDA
- Regulatory Submissions
- Pharmaceutical Industry
- Clinical Trials
- Regulatory Requirements
- Clinical Development
- IND
- Biotechnology
- GCP
- CRO
- Regulatory Filings
- CTMS
- Oncology
- Biopharmaceuticals
- Drug Development
- Regulatory Guidelines
- Regulatory Documentation
- Regulatory Agencies
- ANDAs
- Biologics
- Regulatory Policy
- REMS
- Pharmacovigilance
- Medical Writing
- Commercialization
- Validation
- Immunology
- Sop
- Market Access
- GMP
- Clinical Data Management
- Therapeutic Areas
- CAPA
- Vaccines
- 21 CFR Part 11
- GLP
- Neurology
- Lifesciences
- NDA
- CMC
- Pharmaceutics
- eCTD
- Infectious Diseases
- Cross-functional Team Leadership
- EDC
- Medical Devices
- Technology Transfer
- Medical Affairs
- Change Control
- Program Management
- Cross Functional Team Leadership
- Customer Service
Martin Lessem Summary
- Martin Lessem, based in Massachusetts, United States, is currently a Principal Consultant at Opus Regulatory Inc.. Martin Lessem brings experience from previous roles at Lessem Regulatory Consulting, LLC, Ziopharm Oncology, AbbVie and BioPoint. Martin Lessem holds a 2020 - 2025 Master of Arts - MA in Political Science and Government @ University of Illinois Springfield. With a robust skill set that includes Regulatory Affairs, FDA, Regulatory Submissions, Pharmaceutical Industry, Clinical Trials and more. Martin Lessem has 2 emails and 3 mobile phone numbers on RocketReach.
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