Director, Regulatory Affairs - US Filing Lead

Revolution Medicines•Redwood City, CA

15d•Onsite

About The Position

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 Director of Regulatory Affairs (US Filing Lead) is accountable for driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed. They will manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial. The Director will support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director must have a thorough understanding and be highly experienced in oncology drug development, US NDA regulations, current Health Authority thinking, and have strong leadership & problem-solving ability. Reports into Regulatory Affairs, Global Filing & Registration High-Impact position to lead cross-functional development & regulatory submission activities for registrational oncology programs in the US. Collaborate closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications. Develop strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives. Coordinate NDA Filing and Sub-team rosters for management endorsement. Lead cross-functional NDA kickoff according to global filing plans and framework. Maintain & track an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management. Identify, respond to, and proactively mitigate risks to NDA timelines or regulatory outcomes and report progress to senior management. Drive and/or support modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution. Lead relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement. Motivate, mentor and develop direct reports to ensure development and performance.

Requirements

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 a regulatory strategy role.
Proven success in executing US NDAs (preparation, submission & approval)
Experience filing applications under expedited filing pathways and programs to enable fastest possible regulatory approval.
Demonstrated ability to lead Health Authority interactions and negotiations.
In-depth knowledge of CTD structure and management of dossier components.
Direct experience in oncology drug development including oversight of large, global Phase 3 registrational studies.
Flexibility to support business needs of dynamic registrational programs.
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.

Nice To Haves

An advanced degree is desirable.

Responsibilities

Driving preparation & execution of Regulatory NDA/MAA filings for late-stage oncology programs at RevMed.
Managing end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, CMC, Quality, Translational Medicine and Commercial.
Supporting drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice.
Collaborating closely with Program Teams and Global Regulatory Leads to advance effective & consistent regulatory strategies to enable successful filing of approval of New Drug Applications.
Developing strategic filing plans under expedited regulatory pathways, programs and developing Health Authority initiatives.
Coordinating NDA Filing and Sub-team rosters for management endorsement.
Leading cross-functional NDA kickoff according to global filing plans and framework.
Maintaining & tracking an integrated filing plan including regulatory timelines, modular NDA deliverables, critical path activities, in concert with Regulatory Program Management.
Identifying, responding to, and proactively mitigating risks to NDA timelines or regulatory outcomes and report progress to senior management.
Driving and/or supporting modular NDA Sub-teams (e.g., across Clinical, Non-Clinical, Product Label, etc.) to ensure consistent communication, timely data delivery, and issue resolution.
Leading relevant Health Authority meetings, interactions and query responses and coordinate cross functional team preparation & involvement.
Motivating, mentoring and developing direct reports to ensure development and performance.