Martin Lessem
Principal Consultant at Opus Regulatory, Inc
- Role
- Principal Consultant at Opus Regulatory Inc.
- Location
- Suffolk County, MA, US
- LinkedIn followers
- 500 followers
About Martin Lessem
Martin is a Regulatory Professional with 20+ years of experience in Industry. He has worked on INDs, NDAs, BLAs, NDSs, MAAs and additional supplemental filings for these, as well as Regulatory Risk Management, Regulatory Drug Safety, Competitive Intelligence, and Post-Marketing, among other areas. Additionally he has experience in directing and leading meetings and communications with Health Authorities.
Experience
Principal Consultant
Oct 2022 — Present
Principal Regulatory Strategy Consultant
Education
Widener University Schools of Law
JD, Law
University of Illinois Springfield
Master of Arts - MA, Political Science and Government
2020
Rider University
B.A., Political Science
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
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