David Hymes
Principal Consultant at Opus Regulatory
- Role
- Principal Consultant at Opus Regulatory Inc.
- Location
- Natick, MA, US
- LinkedIn followers
- 500 followers
About David Hymes
Over nineteen years of “hands on” regulatory experience in pharmaceutical and biotechnology industry, with focused drug development knowledge in oncology, vaccines, and rare diseases-Extensive experience with global regulatory strategy and IND/ODD/CTA/PIP/BLA/NDA/MAA filings covering early development through approval-Primary focus is clinical strategy, although also have experience in regulatory operations and CMC
Experience
Principal Consultant
Aug 2017 — Present
Education
Connecticut College
BA, Biology
1988 — 1992
Massachusetts College of Pharmacy and Health Sciences
MS, Regulatory Affairs
Skills
- Clinical Trials
- Regulatory Affairs
- Lifesciences
- Pharmaceutics
- Drug Discovery
- Oncology
- Gmp
- Clinical Research
- Vaccines
- Life Sciences
- Regulatory Submissions
- Strategy
- Cmc
- Biotechnology
- Pharmaceutical Industry
- Fda
- Clinical Development
- Biologics
- Ectd
- Regulations
- Drug Development
- Gcp
- Biopharmaceuticals
- Ind
- Management
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