Senior Director Regulatory Affairs Green Card Jobs
Senior Director Regulatory Affairs roles qualify for EB-2 sponsorship when they require an advanced degree in a life sciences or regulatory discipline, and many large pharmaceutical, biotech, and medical device employers run active PERM pipelines for this title. Your path to a green card starts with finding an employer already set up to sponsor.
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Get Access To All JobsINTRODUCTION
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 Global Head of Regulatory Affairs for Companion Diagnostics (CDx) will define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio. This person will be accountable for the regulatory success of companion diagnostics supporting targeted therapies, ensuring synchronized drug–diagnostic co-development from discovery through global registration and launch. Ensure companion diagnostics are fully integrated into clinical development plans with no downstream regulatory surprises, that drug and CDx approvals are synchronized globally, enabling seamless registrational and commercial execution. Help make the company a leader in targeted oncology CDx development.
The role spans US, EU, and Asia-Pacific markets, with direct responsibility for aligning CDx development with clinical strategy, regulatory pathways, and commercialization plans. The successful candidate will operate as a strategic partner to Translational Sciences, Clinical Development, and Commercial partners.
Enterprise CDx Strategy & Leadership:
- Define and execute a global companion diagnostic regulatory strategy aligned with the company’s precision oncology pipeline and long-term portfolio vision.
- Ensure early and durable integration of biomarker and CDx strategies into clinical development programs from first-in-human through registration.
- Build and lead a high-performing global regulatory CDx organization, fostering a culture of scientific rigor, accountability, collaboration, and execution excellence.
- Own and manage the global regulatory CDx operating budget, ensuring efficient allocation of resources to maximize program value and regulatory success.
Global Regulatory Strategy & External Partnerships:
- Develop and direct global regulatory strategies for companion diagnostics, including:
- FDA (PMA, sPMA, IDE, 21 CFR 809/812)
- EU IVDR (Regulation (EU) 2017/746)
- PMDA (Japan) and other key ex-US authorities
- Ensure alignment of therapeutic and diagnostic regulatory timelines, including coordinated NDA and CDx submissions across programs.
- Have input on the selection, governance, and performance management of diagnostic partners.
- Provide regulatory leadership on bridging strategies, analytical validation plans, and global testing approaches to support registrational claims and post-approval lifecycle management.
Commercial & Launch Readiness:
- Partner with Commercial, Market Access, and Medical Affairs teams to ensure successful global CDx launch readiness, including:
- Labeling alignment
- Reimbursement and access strategy
- Testing infrastructure and adoption
Required Skills, Experience and Education:
- Advanced relevant technical degree in Molecular Biology, Pathology, Genetics, or a related discipline.
- 14+ years of experience in pharmaceutical, biotechnology, or diagnostics organizations, including 10+ years leading companion diagnostics or biomarker-driven programs.
- Demonstrated success leading FDA and global CDx regulatory submissions, including PMA/IDE and IVDR-related activities.
- Deep expertise in NGS and PCR technologies, biomarker validation, and clinical implementation in oncology.
- Proven ability to lead complex, matrixed organizations and drive alignment across scientific, clinical, regulatory, and commercial stakeholders.
Preferred Skills:
- Prior experience supporting registrational oncology trials with companion diagnostics.
- Track record of successful drug–diagnostic co-launches.
- Established external network with diagnostic manufacturers, CROs, and global regulators.
Base Pay Salary Range
$244,000—$305,000 USD
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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
INTRODUCTION
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 Global Head of Regulatory Affairs for Companion Diagnostics (CDx) will define and lead the end-to-end global regulatory diagnostic strategy for the company’s portfolio. This person will be accountable for the regulatory success of companion diagnostics supporting targeted therapies, ensuring synchronized drug–diagnostic co-development from discovery through global registration and launch. Ensure companion diagnostics are fully integrated into clinical development plans with no downstream regulatory surprises, that drug and CDx approvals are synchronized globally, enabling seamless registrational and commercial execution. Help make the company a leader in targeted oncology CDx development.
The role spans US, EU, and Asia-Pacific markets, with direct responsibility for aligning CDx development with clinical strategy, regulatory pathways, and commercialization plans. The successful candidate will operate as a strategic partner to Translational Sciences, Clinical Development, and Commercial partners.
Enterprise CDx Strategy & Leadership:
- Define and execute a global companion diagnostic regulatory strategy aligned with the company’s precision oncology pipeline and long-term portfolio vision.
- Ensure early and durable integration of biomarker and CDx strategies into clinical development programs from first-in-human through registration.
- Build and lead a high-performing global regulatory CDx organization, fostering a culture of scientific rigor, accountability, collaboration, and execution excellence.
- Own and manage the global regulatory CDx operating budget, ensuring efficient allocation of resources to maximize program value and regulatory success.
Global Regulatory Strategy & External Partnerships:
- Develop and direct global regulatory strategies for companion diagnostics, including:
- FDA (PMA, sPMA, IDE, 21 CFR 809/812)
- EU IVDR (Regulation (EU) 2017/746)
- PMDA (Japan) and other key ex-US authorities
- Ensure alignment of therapeutic and diagnostic regulatory timelines, including coordinated NDA and CDx submissions across programs.
- Have input on the selection, governance, and performance management of diagnostic partners.
- Provide regulatory leadership on bridging strategies, analytical validation plans, and global testing approaches to support registrational claims and post-approval lifecycle management.
Commercial & Launch Readiness:
- Partner with Commercial, Market Access, and Medical Affairs teams to ensure successful global CDx launch readiness, including:
- Labeling alignment
- Reimbursement and access strategy
- Testing infrastructure and adoption
Required Skills, Experience and Education:
- Advanced relevant technical degree in Molecular Biology, Pathology, Genetics, or a related discipline.
- 14+ years of experience in pharmaceutical, biotechnology, or diagnostics organizations, including 10+ years leading companion diagnostics or biomarker-driven programs.
- Demonstrated success leading FDA and global CDx regulatory submissions, including PMA/IDE and IVDR-related activities.
- Deep expertise in NGS and PCR technologies, biomarker validation, and clinical implementation in oncology.
- Proven ability to lead complex, matrixed organizations and drive alignment across scientific, clinical, regulatory, and commercial stakeholders.
Preferred Skills:
- Prior experience supporting registrational oncology trials with companion diagnostics.
- Track record of successful drug–diagnostic co-launches.
- Established external network with diagnostic manufacturers, CROs, and global regulators.
Base Pay Salary Range
$244,000—$305,000 USD
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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.
See all 7+ Senior Director Regulatory Affairs jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Senior Director Regulatory Affairs roles.
Get Access To All JobsTips for Finding Green Card Sponsorship in Senior Director Regulatory Affairs
Verify your degree meets EB-2 requirements
An advanced degree in regulatory affairs, pharmacy, biochemistry, or a related life sciences field is the standard EB-2 baseline. A bachelor's plus five years of progressive regulatory experience can substitute if your employer documents the equivalency during PERM.
Target employers with active PERM filings
Use the OFLC Wage Search to confirm whether a prospective employer has recently filed PERM applications for regulatory affairs titles. Companies with existing PERM infrastructure move faster and understand the documentation burden for senior-level roles.
Search green card sponsoring jobs on Migrate Mate
Migrate Mate filters Senior Director Regulatory Affairs openings by green card sponsorship history, so you're applying to employers who have already navigated PERM for comparable roles rather than introducing the process to an unprepared HR team.
Align your FDA submission record with job requirements
PERM requires the employer to demonstrate no qualified U.S. worker is available. Your NDA, BLA, or 510(k) submission history, documented with dates and regulatory outcomes, strengthens the case that your credentials meet genuinely specialized requirements.
Negotiate green card sponsorship timing before accepting an offer
Ask during final-round negotiations whether the company will initiate PERM within your first year. Senior director offers with equity or sign-on bonuses are strong leverage points to formalize a sponsorship commitment before you sign.
Understand EB-2 versus EB-3 before PERM is filed
Your employer chooses the category when filing the I-140. EB-2 requires documenting an advanced degree or equivalent; EB-3 applies if the role is defined at the bachelor's level. The choice affects your priority date and wait time, so confirm it with your employer before DOL filing.
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Find Senior Director Regulatory Affairs JobsSenior Director Regulatory Affairs Green Card Sponsorship: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role typically qualify for EB-2 or EB-3 sponsorship?
Most Senior Director Regulatory Affairs positions qualify for EB-2 because employers routinely require a master's degree or a bachelor's degree with substantial progressive experience in a regulatory discipline. If the employer defines the minimum requirement at the bachelor's level without an advanced degree requirement, EB-3 may apply instead. The PERM labor certification filing locks in the category, so confirm the degree requirement with your employer before the process begins.
How does green card sponsorship differ from H-1B for this role?
H-1B sponsorship is temporary, capped at 85,000 per fiscal year, and subject to a lottery for most applicants. EB-2 and EB-3 green card sponsorship through PERM is permanent residency, has no annual lottery, and results in an I-140 immigrant petition tied to your priority date rather than a temporary status. The PERM process itself takes longer to initiate, typically six months to two years from job offer to I-140 approval, but the outcome is a path to lawful permanent residency rather than a visa renewal cycle.
What does the PERM labor certification process look like for a senior regulatory role?
Your employer files the PERM application with DOL after completing a mandatory recruitment period, usually 30 to 60 days of documented U.S. candidate outreach. For a Senior Director Regulatory Affairs role, the job requirements posted during recruitment must match exactly what appears on the PERM application. DOL audits are more common for senior titles, so employers with in-house immigration counsel or prior PERM experience for regulatory roles handle this more efficiently.
How can I find Senior Director Regulatory Affairs jobs where the employer already sponsors green cards?
Migrate Mate lets you filter regulatory affairs roles specifically by green card sponsorship history, which means you're seeing employers who have already filed PERM applications for comparable titles. Applying to companies with an established sponsorship track record significantly reduces the risk that your offer falls through because the employer is unfamiliar with the PERM process or unwilling to commit to the timeline.
Can my employer start the PERM process while I'm on H-1B status?
Yes. Many foreign professionals in Senior Director Regulatory Affairs roles begin the PERM process while maintaining H-1B status. Filing PERM and an I-140 does not require you to change status, and once your I-140 is approved with a current priority date, you can file for adjustment of status to a green card through USCIS without leaving the U.S. Your H-1B can be extended beyond the standard six-year cap once your I-140 is approved and your priority date is within one year of becoming current.
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