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Talk to Melissa DeSouza, the specialist consultant managing this candidate, located in Toronto

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ttelephone:(416) 367 HAYS (4297)
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Suite 600, 6 Adelaide Street East, Toronto, Ontario, Canada, ON M5C 1H6

Regulatory Affairs Director


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  • Request information for Regulatory Affairs Director

• 10 years of Regulatory Affairs experience with speciality, innovative and generic pharmaceuticals.
• Works well in fast-paced competitive environments with an in-depth knowledge of Health Canada and FDA Regulatory and Quality guidelines.
• 10 years managerial experience (3-15 direct reports). Hands-on leadership includes managing submission processes (includes generating documentation & protocols) for regulatory agencies from multiple jurisdictions and leading acquisition integration.
• Ability to negotiate with Regulatory bodies and develop strategies with key stakeholders. Has completed over 1000 successful filings and approvals.
• Functions as top- and second-tier advisor and generates actionable regulatory strategies with detailed checklists to speed up approvals; forecasts schedules for development, marketing and operations groups. Assigns internal RA staff to ensure submission integrity.

  • Request information for Regulatory Affairs Director