Director, Regulatory Affairs at Revolution Medicines

You're a seasoned regulatory affairs professional with at least 15 years in pharma/biotech and 8 years in regulatory strategy, ideally with an advanced degree i

Work type: hybrid

Location: Redwood City, California, United States

Salary: $211,000 – $264,000/yr

Type: Full-time

Summary

You're a seasoned regulatory affairs professional with at least 15 years in pharma/biotech and 8 years in regulatory strategy, ideally with an advanced degree in a life science field. **What makes it worth a look...** This full-time, hybrid role at Revolution Medicines offers a base salary between USD 211,000 and 264,000 annually, located in Redwood City, California. **You might be a good fit if you...** * Have proven success developing and delivering global regulatory strategies and submissions. * Have direct experience in oncology drug development, including oversight of large Phase 3 and platform studies. * Are skilled at leading health authority interactions and negotiations. * Have prior NDA experience.

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.

• Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.

• Motivate, mentor and develop direct reports to ensure development and performance.

• Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones.

• Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success.

• Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly.

• 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 15 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.

• Proven success in developing and delivering global regulatory strategies and submissions.

• Demonstrated success in leading health authority interactions and negotiations.

• Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies.

• Strong track record in alliance management, coordinating with external development or commercialization partners.

• Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership.

• Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.

• An advanced degree is desirable.

• Experience with dose optimization in oncology.

• 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.

View this job on nocollar jobs