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Join to apply for the Associate Director, Regulatory Affairs role at Revolution Medicines

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.

• Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks.
• Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
• Help drive operational decision making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction.
• Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives.
• Able to proactively identify risks and devise mitigation strategies.
• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
• Perform regulatory research to inform business strategy. Assess and communicate risks.
• Assure that there are no significant interruptions to the business due to regulatory compliance issues.
• Collaborates across the organization at all levels, across functional groups, and with executive management.
• Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations.
  
  

• Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.
• Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.
• Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance. Experience with EU CTR submissions preferred.
  
  

• Direct experience with oncology drug development highly preferred.
• Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.
• Direct experience with FDA expedited programs highly preferred.
  
  

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

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