Remote Vice-président chargé des Affaires Réglementaires​/VP, Regulatory Affairs

Position: Remote Vice-président chargé des Affaires Réglementaires / VP, Regulatory Affairs )
About the role  As the VP Regulatory Affairs, you will:
Lead regulatory activities and team management:
Assist clients with regulatory aspects of drug, biologic, or medical device products; provide counsel, manage the regulatory team (potentially with direct reports), and translate requirements into practical plans while ensuring timely, scientifically valid submissions.
Oversee Health Authority interactions and project leadership:
Lead/participate in Health Authority communications (e.g., meetings, teleconferences); review/author regulatory content for submissions; contribute expertise on drug/device development as a Leadership team member reporting to Senior Leadership, serving on project teams in roles like Subject Matter Expert or Project Lead.
Qualifications   

B.Sc., M.Sc., Ph.D., or equivalent degree in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development.
Advanced regulatory knowledge of drug, biologic, or device development focusing on regulatory requirements for the US, EU, and/or Canada.
RAC credentials preferred.
Critical thinking and analytical skills; financial acumen; influencing and leading teams; risk assessment; problem solving; decision making; strong written and verbal communication skills in English.
Strong computer skills, including SharePoint, Word, Excel, and PowerPoint.
Quality focus.
Strong emotional intelligence, customer-focused leadership, and decision-making skills; innovative, creative, and practical thinking with problem-solving skills.
Open to candidates residing in the United States and Canada.
Benefits   Comprehensive benefits package per location.
Competitive salaries per location.
Departmental study/training budget for further professional development.
Flexible working hours (within reason).
Opportunity for remote/hybrid working depending on location.
Leadership and mentoring opportunities.
Participation in our Buddy Program as a new or existing employee.
Internal growth opportunities and career progression.
Financially rewarding internal employee referral program.

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