18 часов назад
Head, Regulatory Affairs, General Medicine and Vaccines Canada (Biotech)
158 200 - 208 200$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Head, Regulatory Affairs, General Medicine and Vaccines Canada (Biotech): Leading regulatory affairs activities for development and marketed prescription products in General Medicine and Vaccines with an accent on Health Canada submissions, compliance, clinical trial strategy, and team leadership. Focus on achieving timely product approvals, shaping Canadian regulatory strategies, managing stakeholder networks, and developing regulatory professionals.
Location: Toronto, ON, Canada; onsite
Salary: 158,200.00–208,200.00, including target bonus
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.
What you will do
- Lead a team of regulatory professionals supporting development and marketed prescription products in General Medicine and Vaccines.
- Direct preparation and submission of regulatory dossiers to Health Canada to support timely approvals and optimal labelling.
- Ensure regulatory compliance, accurate internal regulatory data, and effective management of clinical trial regulatory activities.
- Evaluate business development opportunities and provide strategic regulatory direction to cross-functional leadership teams.
- Monitor Canadian and international regulatory trends and contribute to Health Canada guidelines and policy reviews.
- Build networks with global regulatory sites, business units, Health Canada, key opinion leaders, and industry advocacy groups.
Requirements
- Bachelor’s degree in science or a health-related field.
- At least 5 years of regulatory affairs, project leadership, or related experience with extensive knowledge of the regulatory environment.
- Strong leadership, managerial, communication, negotiation, project management, and risk analysis skills.
- Experience building effective teams, leading change, prioritizing work, and managing ambiguity.
- Strategic and operational thinking with strong analytical and stakeholder-influence capabilities.
- English proficiency in written and spoken communication is required.
Nice to have
- French language skills.
- Familiarity with Veeva Vault.
- Knowledge of local and international EU and US regulatory trends.
Culture & Benefits
- Supportive, future-focused environment centered on scientific innovation.
- Career development opportunities through promotion or lateral international moves.
- Rewards package that recognizes contribution and impact.
- Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
- Occasional travel is required.
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