Kari-Leigh Smith

Kari-Leigh Smith Email and Phone Number

Regulatory Affairs & Pharmacovigilance Leader | Regulatory Strategy | Pharmacovigilance Compliance | Rare Disease | Navigating complex regulatory issues to secure and maintain marketing authorizations
Kari-Leigh Smith's Location
Ottawa, Ontario, Canada, Canada
About Kari-Leigh Smith

For the past 15+ years, I've been helping pharmaceutical companies bring safe and effective products to the Canadian market. As a regulatory affairs and pharmacovigilance leader, I've worked across many therapeutic areas, navigating complex regulatory landscapes and building innovative strategies to gain and maintain product approvals. I am a results-oriented, collaborative and patient-focused professional who excels in team environments, leveraging my problem-solving skills and adaptability to overcome challenges and drive success. Currently, I am exploring the world of consulting, while continuing to have conversations about leadership roles in pharmaceutical regulatory affairs. If this is an area you're interested in, I'd love to connect.Areas of expertiseRegulatory Strategy, Submissions & Compliance | Product Approvals & Marketing Authorization Maintenance | Pharmacovigilance Requirements | Health Canada | Rare Disease | Neurology | Psychiatry

Kari-Leigh Smith's Current Company Details

Regulatory Affairs & Pharmacovigilance Leader | Regulatory Strategy | Pharmacovigilance Compliance | Rare Disease | Navigating complex regulatory issues to secure and maintain marketing authorizations
Kari-Leigh Smith Work Experience Details
  • Amylyx Pharmaceuticals
    Head, Regulatory Affairs And Pharmacovigilance - Canada
    Amylyx Pharmaceuticals Sep 2022 - May 2024
    Cambridge, Ma, Us
    View
  • Kye Pharmaceuticals Inc
    Director, Scientific Affairs
    Kye Pharmaceuticals Inc Sep 2020 - Sep 2022
  • Sunovion Pharmaceuticals
    Scientific Affairs Senior Manager
    Sunovion Pharmaceuticals Apr 2019 - Sep 2020
    Marlborough, Ma, Us
    View
  • Sunovion Pharmaceuticals
    Scientific Affairs Manager
    Sunovion Pharmaceuticals Apr 2018 - Mar 2019
    Marlborough, Ma, Us
    View
  • Sunovion Pharmaceuticals
    Scientific Affairs Sr Project Manager
    Sunovion Pharmaceuticals Apr 2015 - Mar 2018
    Marlborough, Ma, Us
    View
  • Sunovion Pharmaceuticals
    Scientific Affairs Project Manager
    Sunovion Pharmaceuticals Jan 2009 - Mar 2015
    Marlborough, Ma, Us
    View
  • Sunovion Pharmaceuticals
    Scientific Affairs Associate
    Sunovion Pharmaceuticals Jan 2006 - Dec 2008
    Marlborough, Ma, Us
    View

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What is Kari-Leigh Smith's role at the current company?

Kari-Leigh Smith's current role is Regulatory Affairs & Pharmacovigilance Leader | Regulatory Strategy | Pharmacovigilance Compliance | Rare Disease | Navigating complex regulatory issues to secure and maintain marketing authorizations.

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