OVERVIEW
FOCUS AREAS
More than 25 years of experience in the pharmaceutical industry, at one of the world’s largest CROs, and at FDA
Regulatory strategies that consider commercial implications and minimize timelines, while maintaining a high likelihood of regulatory approval
As Executive Vice President on the Drugs and Biologics Team at ELIQUENT, Robin Huff advises clients regarding regulatory strategy for complex programs. Her experience in the pharmaceutical industry and at FDA enables her to help clients align development efforts with both regulatory and commercial objectives.
Robin has led global regulatory teams and collaborated across functions to drive drug development initiatives from early-stage programs through market launches. She has successfully influenced regulatory policies, shaped clinical trial designs, and secured approvals for numerous therapies, including rare and complex indications. Robin has a proven track record of leading global teams to navigate complex regulatory pathways, achieving timely approvals for critical therapeutic innovations. Robin brings a wealth of experience in regulatory strategy, drug development, and leadership across multiple therapeutic areas.
At ELIQUENT, Robin leverages over 25 years of experience in industry and at FDA to help clients shape clinical development programs and inform critical decisions. Robin joined Eliquent from Takeda Pharmaceuticals where she served as Executive Director, Global Regulatory Affairs. Prior to that she held strategic roles at UCB Biosciences, IQvia, and Talecris Biotherapeutics. Robin began her career at the Center for Drug Evaluation and Research at FDA as a reviewer in the Division of Neuropharmacological Drug Products, later becoming a team leader in the Division of Pulmonary and Allergy Drug Products.
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EDUCATION:
- Ph.D., Pharmacology – Duke University
- B.S., Biochemistry – Virginia Polytechnic Institute and State University
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Professional Experience:
- Takeda Pharmaceuticals – Executive Director, Global Regulatory Affairs
- UCB Biosciences – Global Regulatory Lead, Rare Disease Organization
- IQvia – Global Regulatory Lead, Pediatric and Rare Disease Center of Excellence
- Grifols/Talecris Biotherapeutics – Senior Director, Regulatory Affairs
- FDA Center for Drug Evaluation and Research – Team Leader
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