Oncology Head, Regulatory Affairs
Full-time
AbbVie
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.
When choosing your career path, choose to be remarkable.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, vision care, virology, women’s health , and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
Position Summary
The Oncology Head, Regulatory Affairs leads the Canadian regulatory strategy for AbbVie’s Oncology portfolio, including marketed products, lifecycle management, and pipeline assets. This role is accountable for regulatory direction and execution across a complex and evolving portfolio, ensuring high-quality Health Canada submissions, compliance with applicable requirements, and alignment with business priorities. The role partners closely with global and local cross-functional stakeholders to support timely approvals, launch readiness, and patient access.
Key Responsibilities
- Lead Canadian regulatory strategy and execution for the [therapeutic area / business area]
- Oversee submission, approval, and post-approval activities for clinical trial applications, new and supplemental drug submissions, and related product lifecycle changes
- Lead and support pre-submission interactions with Health Canada, including preparation of materials and strategic meeting support
- Identify and manage regulatory risks to support timely submissions and approvals
- Provide strategic regulatory leadership for development, launch, and post-launch activities
- Partner with local and global Regulatory Affairs, Commercial, Market Access, Medical Affairs, Pharmacovigilance, and Research & Development teams to define submission strategies and support portfolio priorities
- Review supporting documentation for compliance with applicable Health Canada legislation, regulations, policies, and guidance
- Monitor changes to the Canadian regulatory environment and provide comments to draft guidance and external consultations, influencing Canadian regulatory environment and landscape.
- Provide regulatory input to brand teams, early pipeline planning, launch readiness, and business development activities
- Support team effectiveness through coaching, development, and operational excellence
- Develop and oversee departmental budgets, and routinely monitor Regulatory Affairs expenses to ensure operations remain within PLAN budget
- Represent AbbVie on external trade association and related working groups, as applicable
Qualifications
Qualifications
- Bachelor’s degree in a scientific or related discipline required; advanced degree preferred
- Minimum of 10 years of leadership with supervisory role experience in the pharmaceutical or life sciences industry
- Proven experience leading regulatory strategy and execution for development and marketed products
- Strong knowledge of Health Canada regulations, policies, and submission requirements
- Demonstrated success working in a matrixed, cross-functional environment
- Strong leadership, communication, negotiation, and project management skills
- Experience with pharmaceuticals, biologics, medical devices, or other regulated products as applicable to the role
- Fluency (verbal and written) in English required. Fluency (verbal and written) in French required, where applicable
Core Competencies
- Strategic thinking and sound judgment
- Collaboration and influence in a matrix environment
- Accountability for delivery and operational excellence
- Strong problem-solving and risk management skills
- Coaching and talent development
- Clear communication and stakeholder management
AbbVie aims to offer a French-speaking workplace in Quebec and has made efforts to limit English requirements. However, advanced English skills are essential for this role because the position involves working with English-speaking employees, clients, and regions outside Quebec.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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