Senior Director, Regulatory Affairs, Canada

Revolution Medicines

14h•CA$196,000 - CA$245,000•Onsite

About The Position

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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

Requirements

Degree in biological or life sciences, pharmacy, medicine, or related fields.
12+ years of regulatory affairs experience in the pharmaceutical or biotech industry
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.

Nice To Haves

An advanced degree (PhD, PharmD, MSc) is desirable
Significant experience with oncology drug development and checkpoint inhibitors highly preferred
Bilingual English/French is preferred.

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.