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.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

The base pay salary range for this full-time position for candidates working from the location designated on this posting is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working from the location stated on this posting and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

Base Pay Salary Range

$196,000—$245,000 CAD