Experience

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  Fujisawa usa inc.

  Jan 1990 - Jan 1998

  Senior regulatory scientist

  Supported multiple positions with regulatory affairs (labeling, submissions, operations, US and LA regulatory affairs).

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  Manpowergroup

  Jan 1998 - Jan 1999

  Regulatory affairs consultant

  Provided global regulatory support creating registration dossiers for adult medical nutritional products. Also supported product renewals.

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  Abbvie (formerly abbott)

  Jan 1999 - Jan 2014

  Associate director, global regulatory affairs

  Extensive hands on regulatory experience supporting multiple regulatory affairs functions. Regulatory positions held within the following departments - global regulatory lead, US/Canada lead, Asia regional lead Lead, and CMC.

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  Baxter international inc.

  Jan 2014 - Apr 2019

  Director global regulatory affairs

  •Manages a team of Global Regulatory Leads responsible for the design and execution of regulatory strategies supporting new and approved generic drug and premix solutions throughout the product lifecycle.•Collaborates with cross-functional teams and regional counterparts to ensure agreed to strategies are created and executed for projects within area of responsibility.•Regulatory representative with the Business Unit and other internal departments such as the Field Corrective Action Committee, Labeling Safety Committee and Exploratory Product Development Team.•Advises and leads meetings with US regulatory agencies and provides strategic briefing book guidance. Supports local in-country regulatory personal for ex-US meetings.•Lead regulatory team member supporting due diligences for licensing opportunities and new company acquisitions.•Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development teams. Show less

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  Lundbeck

  May 2019 - now

  Responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of small molecule and biological products within the neurology therapeutic area. Experience in rare diseases and orphan drug applications.

  • Senior Director, US Regulatory Strategy

    Oct 2024 - now

  • Director, Regulatory Strategy

    May 2019 - Oct 2024