Full-Time
Director - Filing Lead
Regulatory Affairs
Revolution Medicines
1,001-5,000 employees
Clinical-stage oncology company developing RAS inhibitors
Compensation Overview
$211k - $264k/yr
San Carlos, CA, USA
In Person
On-site at Redwood City, CA headquarters.
Bachelor's, Master's, PhD
 Legal & Compliance (2) |
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- 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.
- Drive preparation and execution of Regulatory NDA/Marketing Authorization Application filings for late-stage oncology programs at Revolution Medicines.
- Manage end-to-end execution of the dossier, ensuring cross-functional coordination and effective communication across Regulatory, Clinical, Biostatistics, Chemistry, Manufacturing and Controls, Quality, Translational Medicine and Commercial.
- Support drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice.
- Lead cross-functional NDA kickoff according to global filing plans and framework.
- Maintain and 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 and involvement.
- Collaborate closely with Program Teams and Global Regulatory Leads to advance effective and 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.
- Motivate, mentor and develop direct reports to ensure development and performance.
- An advanced degree is desirable.
Revolution Medicines develops targeted therapies for cancers caused by RAS mutations, which are found in about 30% of human cancers. The company’s products are small molecules called RAS(ON) inhibitors that work by blocking the active, cancer-promoting form of the RAS protein to stop tumor growth. Unlike older treatments that could only target a few specific mutations, this platform creates inhibitors that can address a much wider range of RAS-driven cancers. The company's goal is to advance these candidates through clinical trials to provide effective treatment options for patients with previously "undruggable" forms of cancer.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Redwood City, California
Founded
2014
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Simplify's Take
What believers are saying
- FDA accepted daraxonrasib NDA on July 22, 2026 for previously treated metastatic pancreatic cancer.
- BeOne will fund a global Phase 3 study and pay milestones plus Asian royalties.
- Cash and marketable securities reached $3.9 billion on June 30, 2026, extending runway.
What critics are saying
- FDA acceptance on July 22, 2026 starts review; rejection kills the lead thesis.
- Commercial launch needs payer adoption against cheap chemotherapy and entrenched oncology incumbents by 2027.
- A failed RASolve 301 readout or safety signal would crater the entire RAS(ON) platform.
What makes Revolution Medicines unique
- Daraxonrasib posted 13.2-month median OS in RASolute 302 on April 13, 2026.
- Revolution Medicines targets active RAS(ON), spanning KRAS G12X, G12D, and G12V biology.
- August 10, 2026 BeOne deal validates a portfolio, not just one pancreatic asset.
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Company Equity
Growth & Insights and Company News
6 month growth
↓ -3%1 year growth
↓ -4%2 year growth
↓ -4%Centric Wealth Management purchased a new position in shares of Revolution Medicines, Inc. (NASDAQ:RVMD – Free Report) during the second quarter, HoldingsChannel.com reports. The fund purchased 3,416 shares of the company’s stock, valued at approximately $505,000. Several other hedge funds and other institutional investors have also recently made changes to their positions in the business. […]
Revolution Medicines has partnered with BeOne Medicines in a multi-part collaboration combining BeOne's oncology assets with Revolution's four clinical RAS(ON) inhibitors. The August 2026 deal grants BeOne exclusive development and commercialisation rights in select Asian markets and commits BeOne to fund a global Phase 3 trial. Revolution Medicines reported a net loss of $644.37 million in Q2 2026 and $1.1 billion over six months. The company currently generates no revenue but projects $2.3 billion in revenue and $402.5 million in earnings by 2029. The partnership shifts near-term risk by offloading Phase 3 costs whilst providing access to milestone and royalty potential. However, the core investment case remains unchanged: regulatory progress and commercialisation of daraxonrasib, with trial execution and spending presenting the biggest risks.
BeOne and Revolution Medicines partner on RAS-targeted oncology combinations and Asian licensing deal. The collaboration pairs BeOne's oncology pipeline with four clinical-stage RAS(ON) inhibitors while giving BeOne regional rights to the Revolution Medicines assets across selected Asian markets. BeOne Medicines and Revolution Medicines have entered a multi-part oncology collaboration covering combination studies involving BeOne pipeline assets and four clinical-stage RAS(ON) inhibitors - daraxonrasib, zoldonrasib, elironrasib and RMC-5127 - alongside exclusive regional development and commercialisation rights in selected Asian markets. The agreement combines BeOne's development and regional commercial infrastructure with Revolution Medicines' RAS-targeted portfolio and creates opportunities to evaluate new combination approaches for patients with RAS-addicted cancers. | Field | Content | | Alert Type | Deal | | Companies | BeOne Medicines; Revolution Medicines | | Deal Type | Clinical development collaboration and regional licensing agreement | | Asset or Company | Revolution Medicines' daraxonrasib, zoldonrasib, elironrasib and RMC-5127; BeOne's BGB-58067 and BG-T187 among the planned combination assets | | Therapy Area(s) | Oncology; RAS-addicted cancers | | Technology or Modality | RAS(ON) inhibitors; PRMT5 inhibitor; trispecific EGFR x MET x MET antibody | | Deal Value | Financial terms were not fully disclosed. Revolution Medicines is eligible to receive development and sales milestone payments plus tiered royalties on net sales from the licensed Asian territories. | | Development Stage | Clinical stage; the four Revolution Medicines RAS(ON) inhibitors are in clinical development, with BeOne also responsible for funding and conducting a global registrational Phase III trial for one of the assets. | | Geography | Global clinical collaboration plus selected Asian markets for licensed rights. Revolution Medicines retains rights outside the licensed territories, including Japan and South Korea. | | What Happened | On 11 August 2026, BeOne Medicines and Revolution Medicines announced a multi-part collaboration focused on RAS-addicted cancers. The companies plan to evaluate combinations of BeOne pipeline assets, including the MTA-cooperative PRMT5 inhibitor BGB-58067 and trispecific EGFR x MET x MET antibody BG-T187, with Revolution Medicines' four clinical-stage RAS(ON) inhibitors: daraxonrasib, zoldonrasib, elironrasib and RMC-5127. Separately, Revolution Medicines granted BeOne exclusive development and commercialisation, or commercialisation-only rights depending on the territory, for the four RAS(ON) inhibitors in selected Asian markets. BeOne will also fund and conduct a global registrational Phase III trial for one of the Revolution Medicines assets. | | Why It Matters | The agreement extends the development opportunities for Revolution Medicines' RAS(ON) portfolio beyond monotherapy by testing combinations with mechanistically different oncology assets from BeOne. It also gives BeOne access to four clinical-stage RAS-targeted programmes across selected Asian markets, allowing the company to use its development and commercial infrastructure to support their regional development and potential launches. | | Supporting Context | RAS alterations are important oncogenic drivers across multiple tumour types and have historically been difficult to target therapeutically. Revolution Medicines is developing RAS(ON) inhibitors designed to target active RAS proteins, while BeOne has a broader oncology pipeline containing potential combination partners with different mechanisms of action. | | Strategic Rationale | Revolution Medicines gains access to BeOne's oncology assets for combination studies while retaining development and commercial rights to its RAS(ON) programmes outside the licensed Asian territories. BeOne gains regional rights to four clinical-stage RAS inhibitors and the opportunity to evaluate its existing oncology pipeline in combinations that could potentially broaden the therapeutic application of both companies' programmes. | | Potential Impact | Successful studies could establish additional combination strategies for RAS-addicted cancers and broaden the development opportunities for both companies' oncology pipelines. Any clinical or commercial impact will depend on trial results and subsequent regulatory approvals. | | Key Takeaway | The collaboration combines BeOne's oncology pipeline and Asian development infrastructure with four Revolution Medicines RAS(ON) inhibitors, creating both new combination programmes and a regional commercial partnership. | | What to Watch | Initiation and results of the planned combination studies, identification of the RAS(ON) inhibitor selected for BeOne's global registrational Phase III trial and subsequent development and regulatory progress across the licensed Asian territories. | | Primary Source | BeOne Medicines / Revolution Medicines collaboration announcement | | Relevant Date | 11 August 2026 | Discover how nuaxia can support your next medical education initiative:
BeOne Medicines and Revolution Medicines announce clinical development and Regional commercialization collaboration. Clinical collaboration enables novel combinations of select BeOne oncology assets with four Revolution Medicines clinical-stage RAS(ON) inhibitors for RAS-addicted cancers Regional rights agreement provides BeOne with exclusive development and commercialization rights to four Revolution Medicines clinical assets in select Asian markets SAN CARLOS, Calif. & REDWOOD CITY, Calif. - BeOne Medicines Ltd. (Nasdaq: ONC; HKEX:...
Revolution Medicines announced second quarter 2026 financial results, reporting cash and marketable securities of $3.9 billion as of 30 June. The company completed concurrent public offerings totalling $2.2 billion in gross proceeds and received $250 million from Royalty Pharma. The FDA accepted the company's new drug application for daraxonrasib to treat previously treated metastatic pancreatic cancer. Over 2,000 patients have received the drug through an expanded access programme since May. The FDA also granted breakthrough therapy designation for daraxonrasib in certain non-small cell lung cancer patients. Research and development expenses rose to $394.9 million from $224.1 million year-over-year, whilst general and administrative expenses increased to $110.2 million from $40.6 million. Net loss totalled $644.4 million, compared to $247.8 million in the prior year quarter.