Michele Dougherty Email & Phone Number
Global CMC Regulatory Lead @ ELIQUENT Life Sciences
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Michele Dougherty Location
- Derwood, MD, US
Michele Dougherty Work
- Global CMC Regulatory Lead @ (October 2025 - Present)
- Head of Regulatory Affairs Practice @ (January 2024 - October 2025)
- President at DataRevive USA, LLC @ (August 2022 - January 2024)
- Vice President, CMC Biologics @ (January 2019 - August 2022)
- Science Policy Analyst, Office of New Drugs, Therapeutic Biologics and Biosimilars Staff @ (January 2017 - November 2018)
- Review Chief, DBRR IV, Office of Biotechnology Products @ (January 2015 - January 2017)
- Product Quality Team Leader, Division of Monoclonal Antibodies @ (July 2013 - December 2014)
- Product Quality Reviewer @ (August 2008 - July 2013)
- Postdoctoral Fellow @ (January 2002 - January 2008)
- Doctoral Candidate @ (January 1996 - January 2001)
- Research Technician II @ (January 1994 - January 1996)
- Quality Assurance Intern @ (January 1993 - January 1994)
- Summer Research Intern @ (January 1990 - January 1993)
Michele Dougherty Education
- Georgetown University
Doctor of Philosophy (Ph.D.) (Tumor Biology)
1996-2001 - Connecticut College
Bachelor’s Degree (Zoology)
1992-1994
Michele Dougherty Skills
- Biologics
- Biosimilars
- Biotechnology
- CMC Documentation
- CMC Strategy
- Clinical Trials
- Drug Development
- FDA Regulations
- GMP Standards
- Government
- IND Submissions
- Life Sciences
- Pharmaceutical Industry
- Policy Analysis
- Program Management
- Quality Assurance
- Regulatory Compliance
- Regulatory Submissions
- Risk Assessment
- Staff Development
- Team Building
- Team Leadership
- U.S. Food and Drug Administration (FDA)
Michele Dougherty Summary
- Michele Dougherty, based in Derwood, MD, US, is currently a Global CMC Regulatory Lead at ELIQUENT Life Sciences. Michele Dougherty brings experience from previous roles at ELIQUENT Life Sciences, DataRevive USA LLC and FDA. Michele Dougherty holds a 1996 - 2001 Doctor of Philosophy (Ph.D.) in Tumor Biology @ Georgetown University. With a robust skill set that includes Biologics, Biosimilars, Biotechnology, CMC Documentation, CMC Strategy and more. Michele Dougherty has 1 emails and 1 mobile phone numbers on RocketReach.
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