Regulatory Affairs Specialist Jobs in USA with Visa Sponsorship
Regulatory Affairs Specialists are in strong demand from H-1B visa and E-3 visa sponsoring employers across pharma, biotech, and medical device companies. Most roles require a science or engineering degree, qualify as specialty occupations, and come with multi-year visa sponsorship. 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 846+ Regulatory Affairs Specialist Jobs
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Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Specialist
Target industries with established sponsorship track records
Pharmaceutical, biotechnology, and medical device companies sponsor Regulatory Affairs Specialists at high rates. These industries have dedicated HR and legal teams experienced with H-1B and E-3 filings, making the process smoother than in smaller or less regulated sectors.
Confirm your degree aligns with the specialty occupation standard
USCIS requires a direct relationship between your degree field and the role. A degree in chemistry, biology, pharmaceutical sciences, or biomedical engineering typically satisfies this. A general business degree alone usually does not, even with years of regulatory experience.
Understand that government affairs roles can complicate cap-exempt petitions
Some Regulatory Affairs roles at universities or nonprofit research institutions may qualify for cap-exempt H-1B status. If your target employer has an academic or nonprofit affiliate, ask whether cap-exempt filing is available before assuming lottery entry is required.
Get your foreign credentials evaluated early
If you completed your degree outside the U.S., a credential evaluation from a NACES-approved organization confirms U.S. equivalency. Employers and immigration attorneys need this before filing. Starting early avoids delays once a job offer is extended.
Highlight regulatory submissions and agency experience in your application
FDA, EMA, or TGA submission experience signals direct value to sponsoring employers. Companies weighing sponsorship costs want clear justification. Concrete examples of IND, NDA, or 510(k) submissions make the hiring case stronger and the sponsorship decision easier.
Ask about visa type flexibility when negotiating your offer
Australians should ask whether the employer will support an E-3 instead of H-1B. The E-3 has no lottery, processes faster, and costs less. Many employers are unaware of it, but most find it straightforward once their immigration attorney reviews the requirements.
Frequently Asked Questions
Do Regulatory Affairs Specialist roles qualify for H-1B sponsorship?
Yes. Regulatory Affairs Specialist is a recognized specialty occupation under H-1B visa standards because the role typically requires a bachelor's degree or higher in a specific scientific or technical field. USCIS has approved H-1B petitions for this title across pharmaceutical, biotech, and medical device companies. Roles that require only general education or where any degree field satisfies the requirement are harder to qualify, so the job description wording matters.
What degree do I need to get visa sponsorship as a Regulatory Affairs Specialist?
Most sponsoring employers require a bachelor's degree in life sciences, chemistry, biomedical engineering, pharmacy, or a related field. Some senior roles accept a combination of a lower-level degree plus relevant work experience under the 3-for-1 rule, where three years of qualifying experience substitutes for one year of education. A degree in an unrelated field makes it significantly harder for the employer to satisfy USCIS's specialty occupation requirement.
Are Australian citizens eligible for the E-3 visa for Regulatory Affairs roles?
Yes. Australian citizens with a qualifying science or engineering degree can work in the U.S. as a Regulatory Affairs Specialist on an E-3 visa. The E-3 has no lottery, is available year-round, and renews in two-year increments with no cap on renewals. Employers need to file a Labor Condition Application with the Department of Labor before you apply, but the overall process is significantly faster than the H-1B.
How competitive is visa sponsorship for Regulatory Affairs Specialists compared to other roles?
More straightforward than many technical roles. Pharmaceutical and medical device companies are experienced sponsors with in-house immigration support, and the specialty occupation case for this title is well-established. The main risk is lottery dependency for H-1B roles, which affects all cap-subject applicants equally. Australians using the E-3 avoid the lottery entirely. Browse current sponsored openings on Migrate Mate to see which employers are actively hiring and sponsoring.
Can I switch employers on an H-1B while working as a Regulatory Affairs Specialist?
Yes, through H-1B portability. If you've been in valid H-1B status for at least 180 days after approval and your new employer files a transfer petition before your current status expires, you can start the new role as soon as the petition is received by USCIS. You don't need to wait for approval. The new employer must file a fresh Labor Condition Application, and the role must still qualify as a specialty occupation.
What is the prevailing wage requirement for sponsored Regulatory Affairs Specialist 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.