Regulatory Affairs Lead Jobs in USA with Visa Sponsorship
Regulatory Affairs Lead roles regularly qualify for H-1B visa and O-1 visa sponsorship, as the position meets USCIS specialty occupation standards. Most employers require a bachelor's degree in a life sciences, chemistry, or engineering field, and many sponsor green cards through the EB-2 or EB-3 pathway. For detailed occupation requirements, see the O*NET profile.
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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.
ROLE
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
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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.
BASIC QUALIFICATIONS
-
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.
PREFERRED QUALIFICATIONS
- An advanced degree is desirable.
COMPENSATION
- Base Pay Salary Range: $211,000—$264,000 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.
ROLE
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.
BASIC QUALIFICATIONS
-
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.
PREFERRED QUALIFICATIONS
- An advanced degree is desirable.
COMPENSATION
- Base Pay Salary Range: $211,000—$264,000 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 2,552+ Regulatory Affairs Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Lead roles.
Get Access To All JobsTips for Finding Regulatory Affairs Lead Jobs
Lead with your regulatory submissions experience
Employers sponsoring Regulatory Affairs Leads want concrete evidence of FDA, EMA, or equivalent agency submissions. Quantify submissions you've led, INDs, NDAs, 510(k)s, so hiring managers can immediately assess your fit and sponsorship value.
Understand your degree's role in the specialty occupation argument
USCIS requires a direct relationship between your degree field and regulatory affairs work. Degrees in pharmacy, biochemistry, biomedical engineering, or chemistry are the strongest fit. Unrelated degrees create risk at the I-129 stage, even with strong experience.
Target employers with an established H-1B filing history
Pharmaceutical companies, medical device manufacturers, and contract research organizations file H-1B visa petitions regularly for this role. Prioritizing employers with a documented sponsorship track record significantly reduces the risk of a first-time denial.
Raise green card sponsorship in second-round interviews
Many employers in regulated industries routinely sponsor Regulatory Affairs Leads for EB-2 or EB-3 green cards after one to two years. Asking about PERM timelines during a second interview is standard practice, not premature, in this field.
Document your role-specific expertise for the RFE scenario
USCIS issues Requests for Evidence for regulatory roles when the job duties seem broad. Keep a file of past regulatory submissions, internal SOPs you've authored, and agency correspondence you've managed, these records are invaluable if your employer needs to respond.
Clarify your authorization status before the offer stage
Disclosing your visa needs early avoids wasted time with employers unwilling to sponsor. Most regulated-industry employers expect sponsorship requests from Regulatory Affairs candidates and factor processing timelines into their hiring plans from the start.
Frequently Asked Questions
Does a Regulatory Affairs Lead role qualify as an H-1B specialty occupation?
Yes, Regulatory Affairs Lead consistently qualifies as a specialty occupation because it requires at minimum a bachelor's degree in a specific technical field, typically pharmacy, chemistry, biomedical engineering, or a related life science. USCIS scrutinizes job descriptions that appear generalist, so the petition should emphasize submission-specific duties and the technical degree requirement rather than broad management responsibilities.
Which employers sponsor H-1B visas for Regulatory Affairs Leads?
Pharmaceutical manufacturers, biologics companies, medical device firms, and contract research organizations are the most active sponsors for this role. Large companies like those in the Fortune 500 pharma sector file regularly, but mid-size device and biotech companies also sponsor frequently given the specialized talent shortage. Browse Migrate Mate to filter for Regulatory Affairs Lead roles at visa-sponsoring employers directly.
Can I qualify for an O-1A visa as a Regulatory Affairs Lead?
It's possible but requires a strong record beyond standard job performance. O-1A requires demonstrated extraordinary ability, peer-reviewed publications on regulatory science, invited presentations at industry conferences, membership on FDA advisory panels, or published guidance contributions would strengthen a petition. A regulatory career that has stayed internal to one company, without external recognition, is unlikely to meet the O-1A bar.
How long does H-1B to green card sponsorship typically take for this role?
For most Regulatory Affairs Leads, the PERM labor certification process takes 12 to 18 months, followed by I-140 approval (6 to 8 months without premium processing). Priority date waiting times then depend heavily on your country of birth. Indian-born applicants face multi-year waits in the EB-2 and EB-3 categories, while applicants born outside India and China often see significantly shorter timelines.
Does my three-year bachelor's degree qualify for H-1B sponsorship in this field?
A three-year bachelor's degree can qualify if USCIS accepts it as equivalent to a U.S. four-year degree, which often requires a credentials evaluation from a recognized assessment organization. For Regulatory Affairs roles, the field of study matters as much as the degree length. A three-year degree in pharmacy or chemistry from an accredited institution generally evaluates favorably; a general science or unrelated degree in any format creates greater petition risk.
What is the prevailing wage requirement for sponsored Regulatory Affairs Lead jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.