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PerkinElmer, Inc

Mountain Lakes, New Jersey

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Aspen Neuroscience, Inc.

San Diego, California

Compliance Insight, Inc.

Cincinnati, Ohio

Yale University

New Haven, Connecticut

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Mirati Therapeutics

San Diego, California

www.bioxceltherapeutics.com

New Haven, Connecticut

www.bioxceltherapeutics.com

New Haven, Connecticut

www.bioxceltherapeutics.com

New Haven, Connecticut

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Co-Diagnostics, Inc.

Salt Lake City, Utah

Philips Electronics

Cambridge, Massachusetts

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ARMI | BioFabUSA

Manchester, New Hampshire

Philips Electronics

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Avanos

Alpharetta , Georgia

Roehm America

Wallingford, Connecticut

Grace Corporation

South Haven, Michigan

Grace Corporation

South Haven, Michigan

MDC Associates, Inc.

Beverly,

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Professional Disposables International

Woodcliff Lake, New Jersey

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Promega

Madison, Wisconsin

US Pharmacopeia

Rockville, Maryland

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Woodcliff Lake, New Jersey

Mammotome

Cincinnati, Ohio

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UCLA Health

Los Angeles, California

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Regulatory Affairs Analyst I
Essential Duties and ResponsibilitiesNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. With supervision, author and compile regulatory submissions in accordance with applicable ICH, CFR, and FDA guidance within specified timelines. This includes but is not limited to ANDA, PAS, CBE and Annual report submissions. Compile high-quality submissions in eCTD format in compliance with applicable regulations and FDA guidance employing use of submission publishing tools and software Participate in meetings and interact with members of the project team and sub-teams to drive submission timelines and determine risks to filing, escalating to man


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