Fraidianie Sévigné
Chief Regulatory Advisor
Bringing a steady, systems-level approach to quality and regulatory strategy, helping the team build products that can stand up to scrutiny across markets, not just in a slide deck. Her strength is practical: aligning cross-functional teams, tightening documentation, anticipating inspection pressure and keeping launches moving without gambling on compliance.
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Experiences
“Good regulation doesn’t slow innovation. It makes sure patients can actually receive it.”
- 22+ years regulatory and quality leadership.
- 130+ products supported through approval in the US & Africa
- 5 years at Pharmascience, leading QA/QC and compliance.
- 20+ years and multiple product classes quality and regulatory operations.
Ripple Therapeutics | VP Operations
Leads operational execution across quality, compliance and delivery, building the internal discipline required to move regulated products forward reliably and on time.
University of Toronto | Senior Mentor to H2i
Leads operational execution across quality, compliance and delivery, building the internal discipline required to move regulated products forward reliably and on time.
Dollarama L.P. | Director, Compliance
Built and led a new compliance function across regulated categories including natural health products, medical devices, OTC products, cosmetics and other regulated goods.
Pharmascience | Head of Quality and Compliance
Owned QA, QC and stability for a manufacturing site, improving quality systems, optimising lab and stability operations and representing the organisation with regulatory authorities.
dynamic medtech
