Director, Regulatory Affairs at Revolution Medicines

Ideal for a seasoned regulatory affairs professional with at least 12 years in the pharmaceutical/biotech industry, including 8 years in regulatory affairs, str

Work type: hybrid

Location: Redwood City, California, United States

Salary: $211,000 – $264,000/yr

Type: Full-time

Summary

Ideal for a seasoned regulatory affairs professional with at least 12 years in the pharmaceutical/biotech industry, including 8 years in regulatory affairs, strategy, and leadership, with a minimum of a bachelor's degree in a life science or related field. **What makes it worth a look...** Revolution Medicines is offering a hybrid role in Redwood City, California with a base salary of $211,000 - $264,000 per year. **You might be a good fit if you...** * Have direct experience with oncology drug development and leading global regulatory submissions. * Possess a thorough understanding of applicable oncology drug development regulations and health authority thinking. * Are skilled in policy and process development within regulatory affairs. * Have experience with NDA submissions.

Job Description

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:

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.

• Deliver sound regulatory strategy to program teams.

• Motivate, mentor and develop direct reports.

• Ensure drug development programs are fully resourced for applicable stages of development.

• Anticipate upcoming work; ensure robust and effective regulatory strategy support.

• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.

• Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs.

• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.

• Demonstrated success in leading regulatory submissions globally.

• Direct experience with oncology drug development.

• Experienced in representing Regulatory 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.

• An advanced degree is desirable.

• Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.

• Prior NDA experience is highly preferred.

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City 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.

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