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 JobsLocation: New York
Other locations: Anywhere in Region
Salary: Competitive
Date: Jun 23, 2026
Requisition ID: 1719977
At EY, we’re all in to shape your future with confidence.
We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.
EY - Life Sciences Regulatory Submissions - Senior Manager
National Risk – Enterprise Risk – Reg Comp – Life Sciences – Reg Submissions – Senior Manager
Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and impacting patient safety.
The opportunity
The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally:
- Quality Management Systems
- Regulatory Affairs
- Laboratory Information Management Systems
- Computer Systems Validation
EY is seeking a dynamic and experienced Senior Manager to lead EY’s Life Sciences Regulatory Submissions practice. This role is pivotal in driving growth and establishing EY as a leader in the Regulatory Compliance sector, particularly in Regulatory Submissions. The ideal candidate will have a deep understanding of the life sciences market, a proven track record in regulatory compliance, and the ability to develop and execute strategies that enhance our service offerings and client relationships.
Your key responsibilities
Your time will be spent leading client engagement teams to deliver projects in the life sciences domain, including:
- Strategic Growth: Drive the growth of Regulatory Submissions by identifying and capitalizing on market opportunities
- Market Understanding: Develop a comprehensive understanding of the life sciences regulatory landscape, including key players, trends, and competitive dynamics.
- Solution Development: Collaborate with internal teams to develop innovative solutions that address client needs in regulatory submissions, ensuring alignment with market demands and compliance requirements.
- Team Development: Assess and validate the skillsets of the team, ensuring that the practice is equipped with the necessary expertise to deliver high-quality services. Foster a culture of continuous improvement and professional development.
- Go-To-Market Strategy: Work with leadership in the development and execution of a robust go-to-market (GTM) strategy that effectively communicates EY's value proposition to clients. Engage with clients to understand their challenges and position EY as a trusted advisor.
- Client Engagement: Build and maintain strong relationships with key stakeholders in client organizations, particularly in high-stakes regulatory submission scenarios involving the FDA. Ensure that clients respect and value EY's insights and recommendations.
- Practice Development: Play a key role in building out the Regulatory Compliance practice, including identifying new service offerings, enhancing existing capabilities, hiring the team, and driving operational excellence.
You will also be expected to lead teams in consistently delivering high-quality client services by leveraging your extensive technical expertise and professional knowledge. In addition, you will be responsible for nurturing and maintaining long-term client relationships, ensuring a strategic and collaborative approach to project delivery.
Skills and attributes for success
- Proven experience in regulatory compliance within the life sciences sector, with a focus on regulatory submissions.
- Strong understanding of the FDA regulatory process and the associated risks and challenges.
- Demonstrated ability to drive revenue growth and develop successful business strategies.
- Excellent leadership and team management skills, with a track record of building high-performing teams.
- Strong analytical and problem-solving skills, with the ability to translate market insights into actionable strategies.
- Exceptional communication and interpersonal skills, with the ability to engage and influence senior stakeholders.
To qualify for the role you must have
- A bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)
- 8+ years of Regulatory Affairs experience with a strong focus on regulatory submissions in the life sciences industry.
- Demonstrated experience leading major global submissions (FDA and at least one other major health authority).
- Strong working knowledge of applicable regulations (e.g., 21 CFR, ICH guidelines, EU regulations).
- Experience with global regulatory strategies and lifecycle management.
- Strong project management and risk management capabilities.
- Prior experience supporting inspections, health authority interactions, or regulatory inquiries.
- Ability to contribute to go-to-market strategies, thought leadership, or practice development initiatives.
Ideally, you’ll also have
- Proven experience managing teams and complex, cross-functional initiatives.
- Excellent written and verbal communication skills, with the ability to engage senior stakeholders.
- Experience working in a consulting, CRO, or matrixed corporate environment preferred.
- Ability to travel domestically and internationally. Travel expectation up to 40%.
What we look for
We are interested in passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry. If you have a strong passion for helping businesses drive measurable value while serving patients, then this role is for you.
What we offer you
At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more.
We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $138,100 to $315,600. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $165,700 to $358,700. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options.
Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year.
Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being.
Are you ready to shape your future with confidence? Apply today.
EY accepts applications for this position on an ongoing basis.
For those living in California, please click here for additional information.
EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities.
EY | Building a better working world
EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.
Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.
EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.
EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law.
EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY’s Talent Shared Services Team (TSS) or email the TSS at ssc.customersupport@ey.com.
Location: New York
Other locations: Anywhere in Region
Salary: Competitive
Date: Jun 23, 2026
Requisition ID: 1719977
At EY, we’re all in to shape your future with confidence.
We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.
EY - Life Sciences Regulatory Submissions - Senior Manager
National Risk – Enterprise Risk – Reg Comp – Life Sciences – Reg Submissions – Senior Manager
Our clients operate in a world where achieving high performance is just as important as the patients they serve. EY’s Life Sciences team advises clients in the Life Sciences sector on setting strategic decisions to address risks impacting their organization’s performance and impacting patient safety.
The opportunity
The Life Sciences Risk Consulting Services team focuses on biotechnology, pharmaceutical, medical device manufacturers, and the medical technology industry. You will be an integral part of this team helping clients identify, manage, and respond to risks while accelerating performance and maintaining growth. Our team advises clients on aligning risk and business objectives from strategy to execution, and improving coordination of risk activities across the organization for better outcomes. This involves working with life sciences clients to develop business processes, and design and implement systems to effectively manage these areas governed by the FDA and similar regulatory bodies globally:
- Quality Management Systems
- Regulatory Affairs
- Laboratory Information Management Systems
- Computer Systems Validation
EY is seeking a dynamic and experienced Senior Manager to lead EY’s Life Sciences Regulatory Submissions practice. This role is pivotal in driving growth and establishing EY as a leader in the Regulatory Compliance sector, particularly in Regulatory Submissions. The ideal candidate will have a deep understanding of the life sciences market, a proven track record in regulatory compliance, and the ability to develop and execute strategies that enhance our service offerings and client relationships.
Your key responsibilities
Your time will be spent leading client engagement teams to deliver projects in the life sciences domain, including:
- Strategic Growth: Drive the growth of Regulatory Submissions by identifying and capitalizing on market opportunities
- Market Understanding: Develop a comprehensive understanding of the life sciences regulatory landscape, including key players, trends, and competitive dynamics.
- Solution Development: Collaborate with internal teams to develop innovative solutions that address client needs in regulatory submissions, ensuring alignment with market demands and compliance requirements.
- Team Development: Assess and validate the skillsets of the team, ensuring that the practice is equipped with the necessary expertise to deliver high-quality services. Foster a culture of continuous improvement and professional development.
- Go-To-Market Strategy: Work with leadership in the development and execution of a robust go-to-market (GTM) strategy that effectively communicates EY's value proposition to clients. Engage with clients to understand their challenges and position EY as a trusted advisor.
- Client Engagement: Build and maintain strong relationships with key stakeholders in client organizations, particularly in high-stakes regulatory submission scenarios involving the FDA. Ensure that clients respect and value EY's insights and recommendations.
- Practice Development: Play a key role in building out the Regulatory Compliance practice, including identifying new service offerings, enhancing existing capabilities, hiring the team, and driving operational excellence.
You will also be expected to lead teams in consistently delivering high-quality client services by leveraging your extensive technical expertise and professional knowledge. In addition, you will be responsible for nurturing and maintaining long-term client relationships, ensuring a strategic and collaborative approach to project delivery.
Skills and attributes for success
- Proven experience in regulatory compliance within the life sciences sector, with a focus on regulatory submissions.
- Strong understanding of the FDA regulatory process and the associated risks and challenges.
- Demonstrated ability to drive revenue growth and develop successful business strategies.
- Excellent leadership and team management skills, with a track record of building high-performing teams.
- Strong analytical and problem-solving skills, with the ability to translate market insights into actionable strategies.
- Exceptional communication and interpersonal skills, with the ability to engage and influence senior stakeholders.
To qualify for the role you must have
- A bachelor’s or master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred)
- 8+ years of Regulatory Affairs experience with a strong focus on regulatory submissions in the life sciences industry.
- Demonstrated experience leading major global submissions (FDA and at least one other major health authority).
- Strong working knowledge of applicable regulations (e.g., 21 CFR, ICH guidelines, EU regulations).
- Experience with global regulatory strategies and lifecycle management.
- Strong project management and risk management capabilities.
- Prior experience supporting inspections, health authority interactions, or regulatory inquiries.
- Ability to contribute to go-to-market strategies, thought leadership, or practice development initiatives.
Ideally, you’ll also have
- Proven experience managing teams and complex, cross-functional initiatives.
- Excellent written and verbal communication skills, with the ability to engage senior stakeholders.
- Experience working in a consulting, CRO, or matrixed corporate environment preferred.
- Ability to travel domestically and internationally. Travel expectation up to 40%.
What we look for
We are interested in passionate leaders with strong delivery capability, and a strong desire to stay on top of trends in the life sciences industry. If you have a strong passion for helping businesses drive measurable value while serving patients, then this role is for you.
What we offer you
At EY, we’ll develop you with future-focused skills and equip you with world-class experiences. We’ll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more.
We offer a comprehensive compensation and benefits package where you’ll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $138,100 to $315,600. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $165,700 to $358,700. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options.
Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year.
Under our flexible vacation policy, you’ll decide how much vacation time you need based on your own personal circumstances. You’ll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being.
Are you ready to shape your future with confidence? Apply today.
EY accepts applications for this position on an ongoing basis.
For those living in California, please click here for additional information.
EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities.
EY | Building a better working world
EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.
Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.
EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.
EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law.
EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY’s Talent Shared Services Team (TSS) or email the TSS at ssc.customersupport@ey.com.
See all 2,447+ 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.