The Opportunity: Senior Director, Regulatory Affairs – Canada

Reporting to the Vice-President & General Manager (GM) Canada, this role will serve as the head of Regulatory Affairs in Canada. In collaboration with the Canadian Leadership Team and working closely with Global and Regional Regulatory teams, the incumbent will lead the development and execution of the regulatory strategy for the company’s portfolio in Canada. The role will provide strategic and hands-on regulatory leadership across the product lifecycle, ensuring Canadian regulatory requirements and considerations are incorporated into Global and Regional development and commercialization plans.

The Senior Director will serve as a strategic partner to Global Regulatory teams, ensuring alignment between Canadian regulatory strategy and the company’s broader Global and Regional objectives. The incumbent will independently represent Regulatory Affairs on Global, Regional, and Canadian cross-functional teams and provide strategic regulatory expertise across oncology programs. This role requires a strong understanding of oncology drug development and the Canadian regulatory environment, as well as the ability to lead proactive engagement with Health Canada to support successful and timely regulatory outcomes.

The role will report to the Vice-President & General Manager, Canada, with a dotted-line reporting relationship to Global Regulatory Affairs leadership.

Responsibilities:

Lead the development and execution of Canadian regulatory strategies for assigned programs across all stages of the product lifecycle, from early development through approval and post-approval, in support of Global and Regional objectives.

Develop, plan, and execute regulatory pathways for Marketing Authorization Applications and lifecycle management activities in Canada.

Ensure Canadian regulatory submissions meet applicable requirements, quality standards, and established timelines.





Serve as the primary regulatory contact for interactions with Canadian health authorities, including Health Canada.

Lead regulatory preparations and provide Canadian expertise for Scientific Advice Briefing Packages and other relevant regulatory applications and development requirements.

Provide Canadian regulatory input into clinical trial design, labelling strategy, post-marketing activities, and regulatory commitments.

Partner closely with Global Regulatory leads to ensure alignment between Canadian, Regional, and Global regulatory strategies.

Provide and incorporate Canadian regulatory, clinical, and market insights into integrated disease-area and product strategies.

Act as a strategic regulatory partner to R&D;, Medical Affairs, Safety, Market Access, and Commercial teams at the Canadian, Regional, and Global levels.

Ensure compliance with all applicable Canadian regulatory, pharmacovigilance, medical governance, and internal Company requirements.

Identify, assess, and communicate the potential impact of evolving Canadian regulatory requirements, guidelines, policies, and trends to relevant cross-functional stakeholders.

Oversee and manage relationships with external vendors and Contract Research Organizations (CROs), ensuring timely and high-quality regulatory submissions and approvals for assigned products.

Provide leadership and direction to direct reports, ensuring appropriate prioritization and allocation of resources to achieve Canadian, Regional, and Company objectives.

Coach, mentor, and develop direct reports while ensuring the team operates in accordance with Company and departmental policies, procedures, and standards.

Skills,



Experience and Education:

Degree in biological or life sciences, pharmacy, medicine, or a related discipline. An advanced degree (PhD, PharmD, MSc, or equivalent) is preferred.

12+ years of progressive Regulatory Affairs experience within the pharmaceutical or biotechnology industry.

Significant experience in oncology drug development, with experience across innovative and targeted oncology therapies strongly preferred.

Deep understanding of Canadian regulatory frameworks, requirements, and guidelines relevant to oncology drug development and commercialization.

Demonstrated success leading Health Canada regulatory submissions and achieving successful regulatory outcomes.

Direct, hands-on experience preparing and submitting large and complex regulatory documentation to support health authority review and approval processes, including post-approval activities.

Demonstrated ability to address complex regulatory challenges, engage effectively with health authorities and lead internal teams in the development and execution of regulatory strategies.

Experience representing Regulatory Affairs on cross-functional teams and effectively presenting regulatory strategies, recommendations, and risks to senior leadership.

Excellent interpersonal, written, and presentation skills, with the ability to clearly communicate complex regulatory issues and strategies to diverse audiences.

Ability to thrive in a quick-paced and evolving environment, manage multiple priorities, and operate independently with limited supervision.

Excellent planning and organizational capabilities, with demonstrated ability to manage multiple projects and deliver against demanding timelines.

Strong leadership, communication, influencing, and stakeholder management capabilities.

Strong project management and organizational skills.

Bilingual proficiency in English and French preferred.

#J-18808-Ljbffr

📌 Senior Director Regulatory Affairs (Ontario)
🏢 MedAccess Recruiters
📍 Ontario