Stu Kim Email and Phone Number
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I am a regulatory affairs professional and life sciences attorney who focuses on applying federal, state and international laws to the regulation of prescription drugs and medical devices. I previously have worked for three pharmaceutical companies, a Fortune 15 medical device manufacturer/distributor, a Washington, D.C. law firm, and a federal bioethics advisory commission. I have a strong biomedical, regulatory, legal and policy background.
Catalyst Pharmaceuticals, Inc.
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Legal Counsel - PharmaceuticalCatalyst Pharmaceuticals, Inc. May 2024 - PresentCoral Gables, Florida, Us -
Member - Deib Expert PanelUs Pharmacopeia Mar 2024 - PresentRockville, Maryland, UsReview and implement USP Diversity, Equity, Inclusion, and Belonging (DEIB) curriculum across Expert Committees and Expert Panels; contribute to Expert Volunteer recruitment by adding to network of highly sought-after, diverse, and desirable volunteers; and help implement Health Equity Guiding Principles and establish measurable outcomes that advance health impact. -
Vice President, Regulatory Affairs And Legal AffairsNorthstar Medical Radioisotopes, Llc Jul 2020 - Feb 2024Beloit, Wisconsin, UsManaged regulatory and legal issues related to federal (FDA, USP, FTC) and state regulation of radio-pharmaceuticals and medical radioisotopes. -
Vice President, Associate General Counsel - RegulatoryCardinal Health Apr 2016 - Jul 2020Dublin, Oh, UsProvided legal and regulatory counsel and guidance related to U.S. (FDA, FTC, CBP, USP, Proposition 65) and international (Health Canada, EC) regulation of medical devices, over-the-counter (OTC) and prescription drugs and related medical supplies. Served as a member of the Corporate Diversity & Inclusion Steering Council. -
Associate General Counsel, Regulatory AffairsMallinckrodt Pharmaceuticals Aug 2008 - Mar 2016Dublin, Ireland, IeManaged legal, regulatory and compliance issues related to federal (FDA, DEA, USP, FTC), state and international regulation of branded and generic prescription drugs, bulk pharmaceuticals, imaging contrast agents and related medical devices. -
Regulatory CounselCephalon, Inc. Jan 2005 - Jan 2008UsHandled legal, regulatory and compliance issues related to federal (FDA, FTC, DEA) and state regulation of company prescription drug products. -
ConsultantAgency For Healthcare Research And Quality Feb 2006 - Dec 2006Rockville, Md, Us• Invited to participate in writing and editing policy handbook on best practices for developing and using patient registries• This project is part of a federal mandate to assess the value of new and expensive prescription drugs, medical devices, and biologics in order to control federal spending on health care• Participating federal agencies include AHRQ, CMS, FDA, CDC, and DHHS• As one of two industry representatives and one of three lawyers invited, my contribution focuses on legal and ethical issues regarding the development and use of patient registries -
Counsel, Legal RegulatoryAbbott Laboratories Feb 2002 - Dec 2004Abbott Park, Illinois, UsHandled legal, regulatory, quality and compliance issues related to federal (FDA and FTC) and state regulation of various company products, including human and animal drugs, medical devices, biologics, infant formula, and nutritionals. -
Associate, Food And DrugMckenna Long & Aldridge Llp Oct 2000 - Feb 2003Washington, Dc, UsPerformed legal tasks related to the regulation of foods, human and animal drugs, medical devices, biologics, dietary supplements and cosmetics. -
Research AnalystNational Bioethics Advisory Commission Sep 1999 - Oct 2000Conducted legal and policy research and prepared memoranda for commissioners on human embryonic stem cells and protection of research participants, both domestically and internationally; helped in writing and editing of commission reports.
Stu Kim Skills
Stu Kim Education Details
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University Of Wisconsin Law SchoolLaw -
University Of Wisconsin-MadisonAnatomy -
University Of Notre DameBiological Sciences -
Lafayette CollegeBiology
Frequently Asked Questions about Stu Kim
What company does Stu Kim work for?
Stu Kim works for Catalyst Pharmaceuticals, Inc.
What is Stu Kim's role at the current company?
Stu Kim's current role is Legal Counsel - Pharmaceutical at Catalyst Pharmaceuticals, Inc..
What is Stu Kim's email address?
Stu Kim's email address is st****@****lth.com
What is Stu Kim's direct phone number?
Stu Kim's direct phone number is (314) 654*****
What schools did Stu Kim attend?
Stu Kim attended University Of Wisconsin Law School, University Of Wisconsin-Madison, University Of Notre Dame, Lafayette College.
What skills is Stu Kim known for?
Stu Kim has skills like Fda, Regulatory Affairs, Pharmaceutical Industry, Regulatory Requirements, Medical Devices, Clinical Trials, Healthcare, Biotechnology, Regulatory Submissions, Technology Transfer, Research, Clinical Development.
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