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G&L Healthcare Advisors

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Edwards Lifesciences

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Agendia, Inc.

Irvine, California

Eisai

Nutley, New Jersey

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Vaughan Regional Medical Center

Selma, Alabama

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Fred Hutchinson Cancer Center

Seattle, Washington

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Plano, Texas

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Shreveport, Louisiana

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Kindred Hospitals

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Duke University Health System

Raleigh, North Carolina

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Surgenex

Scottsdale, Arizona

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The Brooklyn Hospital Center

Brooklyn, New York

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois

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Kindred Hospitals

La Mirada, California

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Senior Director Regulatory Affairs
Responsibilities: Actively participate in client meetings as a regulatory affairs Subject Matter Expert. Assess client programs and provide regulatory consultation, gap analysis and recommendations for regulatory strategies and path forward. Assess situations and provide strategic regulatory pre-marketing and post-marketing advice based on regulatory experience and past successes, and in compliance with the applicable regulations. Plan submission strategies and health authority communications to develop successful product development plans to fruition through successful applications and submission life cycle management. Serve as the client’s US Agent with the FDA for applications to CDER and CBER. Represent clien


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