Senior Director, Regulatory Affairs, Canada

The Opportunity:

We seek a strategic and hands-on Senior Director, Regulatory Affairs, Canada who will play a critical role in leading and executing the regional regulatory strategy for our portfolio in Canada. The Senior Director will serve as a strategic partner to Global Regulatory Teams, ensuring alignment of the Canada regulatory strategy with the global and regional company’s objectives. In addition, independently represent regulatory affairs in global and regional cross-functional teams and provide targeted, strategic expertise of one or more therapeutic areas for oncology programs across the Global and JPAC organizations. The candidate must have a thorough understanding of oncology drug development, applicable Canada regulations and is responsible for driving proactive engagement with health authorities including the Health Canada ensuring successful regulatory outcomes.

The role will report to the Vice President, General Manager, Canada and dotted line to the SVP, Head of Regulatory Affairs

Primary Responsibilities:

• Lead the development and execution of local regulatory strategy for assigned programs across all stages of development (early development through post-approval) supporting global and regional goals

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

• Ensure regulatory submissions meet regulatory requirements and timelines

• Serve as primary contact for regulatory interactions with the Canadian Agencies, e.g. (Health Canada)

• Lead the preparations, provide regional regulatory expertise, and review Scientific Advice Briefing Packages, Orphan Designation Applications, Paediatric Plans

• Provide regional regulatory input to clinical trial design, labelling strategy, post-marketing activities and commitments

• Partner with global regulatory leads to ensure alignment between global and regional strategies

• Provide and incorporate regional regulatory, clinical, and market insights into integrated disease area and product strategies

• Act as a strategic partner to R&D, medical affairs, safety, market access, and commercial local, global and regional teams

• Ensure compliance with all applicable regulatory, pharmacovigilance, and medical governance requirements

• Identify, assess and communicate cross-functionally impact of relevant Canadian regulatory requirements, guidelines and trends

• Oversee and accountable for working with outside vendors and Contract Research Organizations (CROs) to ensure timely submissions and approvals of assigned products

• Provide managerial leadership & direction to direct reports allowing appropriate prioritization of resources to achieve corporate and regional goals

• Provide coaching, mentoring, and development of direct reports, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures.

Required Skills, Experience and Education:

• Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable

• 12+ years of regulatory affairs experience in the pharmaceutical or biotech industry

• Significant experience with oncology drug development and checkpoint inhibitors highly preferred

• Deep understanding of Canadian regulatory frameworks and oncology guidelines

• Demonstrated success in Health Canada submissions and approvals

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy

• Experience in representing Regulatory Affairs on cross-functional teams and presenting to senior management

• Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex regulatory strategies to diverse audiences

• Thrives in fast-paced, dynamic environment and ability to multi-task independently with limited supervision

• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines

• Excellent leadership, communication and stakeholder management skills

• Strong project management and organizational skills.

• Bilingual English/French is preferred.

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