Regulatory Affairs Manager Jobs in USA with Visa Sponsorship
Regulatory Affairs Managers are strong H-1B visa sponsorship candidates. The role qualifies as a specialty occupation requiring a bachelor's degree or higher in a life sciences, pharmacy, or engineering field, and employers in pharma, biotech, and medical devices sponsor consistently. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsABOUT PAREXEL
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).
ABOUT THE ROLE
We are seeking a Global Labeling Specialist (Operations) to join our team in a remote capacity. As a Global Labeling Specialist (Operations), you will support labeling operations and regulatory compliance activities that ensure safe and effective use of innovative medicines for patients and healthcare providers globally. This position plays a key role in labeling document management, regulatory compliance, artwork coordination, and maintaining labeling governance across multiple regions. You'll collaborate with cross-functional regulatory, operations, and regional teams, follow industry-standard processes, and contribute to labeling excellence from product development through lifecycle management. Responsibilities include coordinating labeling operations, managing regulatory-compliant labeling documents, overseeing regional implementation, and maintaining labeling compliance, with opportunities to deepen your expertise in global regulatory labeling and influence patient safety outcomes.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory excellence, cross-functional collaboration, and ensuring labeling governance. With diverse teams and continuous learning opportunities, the Global Labeling Specialist (Operations) can explore career paths and expand skills across regulatory affairs and clinical development.
KEY RESPONSIBILITIES
- Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to ensure changes to planned artwork activities and implementation timelines are communicated effectively
- Record regulatory assessments and ensure the Change Management System is appropriately linked to the Regulatory Tracking System
- Support the development and maintenance of regulatory-compliant, competitive, and high-quality labeling documents throughout the product lifecycle, including Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI), and US Prescribing Information (USPI)
- Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System (EDMS) and regulatory tracking systems
- Track implementation of labeling updates across regions and countries, supporting Regional and Local Regulatory Leads in responding to Health Authority queries and identifying country-specific labeling differences
- Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems, and create, maintain, and update regulatory labeling procedures and SOPs
- Provide training to internal stakeholders and new joiners on labeling process requirements and maintain current knowledge of global labeling regulations and governance standards
CANDIDATE PROFILE
You'll thrive in this role if you bring:
- Expertise in regulatory labeling operations, document management systems, and change management processes
- Experience working in pharmaceutical or biotechnology regulatory environments with a deep understanding of global labeling requirements
- The ability to collaborate across cross-functional teams and communicate clearly with regulatory, operations, and regional stakeholders
- A patient-focused mindset and exceptional attention to detail in managing regulatory-compliant labeling documents
- Comfort working with regulatory tracking systems, document management systems, and change management platforms
REQUIRED QUALIFICATIONS
- 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations supporting innovative medicines
- Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment
- Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development
- Proven experience with document management systems, regulatory tracking systems, and change management platforms
- Strong communication, organization, and problem-solving skills
- Demonstrated understanding of the importance of labeling governance and compliance
PREFERRED QUALIFICATIONS
- Bachelor's degree in a scientific or medically related discipline
- Experience with Structured Product Labeling (SPL) and FDA submission processes
- Familiarity with Electronic Document Management Systems (EDMS) and regulatory tracking platforms
- Knowledge of ICH-GCP and international regulatory requirements across multiple regions
BENEFITS AND COMPENSATION
- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
For a complete list of benefits, please visit www.parexel.com/us-benefits.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
LI-LB1
LI-REMOTE
ABOUT PAREXEL
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).
ABOUT THE ROLE
We are seeking a Global Labeling Specialist (Operations) to join our team in a remote capacity. As a Global Labeling Specialist (Operations), you will support labeling operations and regulatory compliance activities that ensure safe and effective use of innovative medicines for patients and healthcare providers globally. This position plays a key role in labeling document management, regulatory compliance, artwork coordination, and maintaining labeling governance across multiple regions. You'll collaborate with cross-functional regulatory, operations, and regional teams, follow industry-standard processes, and contribute to labeling excellence from product development through lifecycle management. Responsibilities include coordinating labeling operations, managing regulatory-compliant labeling documents, overseeing regional implementation, and maintaining labeling compliance, with opportunities to deepen your expertise in global regulatory labeling and influence patient safety outcomes.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory excellence, cross-functional collaboration, and ensuring labeling governance. With diverse teams and continuous learning opportunities, the Global Labeling Specialist (Operations) can explore career paths and expand skills across regulatory affairs and clinical development.
KEY RESPONSIBILITIES
- Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to ensure changes to planned artwork activities and implementation timelines are communicated effectively
- Record regulatory assessments and ensure the Change Management System is appropriately linked to the Regulatory Tracking System
- Support the development and maintenance of regulatory-compliant, competitive, and high-quality labeling documents throughout the product lifecycle, including Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI), and US Prescribing Information (USPI)
- Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System (EDMS) and regulatory tracking systems
- Track implementation of labeling updates across regions and countries, supporting Regional and Local Regulatory Leads in responding to Health Authority queries and identifying country-specific labeling differences
- Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems, and create, maintain, and update regulatory labeling procedures and SOPs
- Provide training to internal stakeholders and new joiners on labeling process requirements and maintain current knowledge of global labeling regulations and governance standards
CANDIDATE PROFILE
You'll thrive in this role if you bring:
- Expertise in regulatory labeling operations, document management systems, and change management processes
- Experience working in pharmaceutical or biotechnology regulatory environments with a deep understanding of global labeling requirements
- The ability to collaborate across cross-functional teams and communicate clearly with regulatory, operations, and regional stakeholders
- A patient-focused mindset and exceptional attention to detail in managing regulatory-compliant labeling documents
- Comfort working with regulatory tracking systems, document management systems, and change management platforms
REQUIRED QUALIFICATIONS
- 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations supporting innovative medicines
- Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment
- Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development
- Proven experience with document management systems, regulatory tracking systems, and change management platforms
- Strong communication, organization, and problem-solving skills
- Demonstrated understanding of the importance of labeling governance and compliance
PREFERRED QUALIFICATIONS
- Bachelor's degree in a scientific or medically related discipline
- Experience with Structured Product Labeling (SPL) and FDA submission processes
- Familiarity with Electronic Document Management Systems (EDMS) and regulatory tracking platforms
- Knowledge of ICH-GCP and international regulatory requirements across multiple regions
BENEFITS AND COMPENSATION
- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
For a complete list of benefits, please visit www.parexel.com/us-benefits.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
LI-LB1
LI-REMOTE
See all 1,013+ Regulatory Affairs Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Manager roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Manager
Target industries with established sponsorship programs
Pharmaceutical, biotechnology, and medical device companies sponsor Regulatory Affairs Managers at high rates. These industries rely on specialized expertise and are accustomed to H-1B petitions, making them significantly more receptive than general manufacturing or consumer goods employers.
Match your degree field to the role precisely
H-1B approval depends on your degree aligning with the regulatory function. Degrees in pharmacy, biochemistry, biomedical engineering, or regulatory science are strongest. A general biology or chemistry degree can work but may require supporting documentation connecting your coursework to the role.
Highlight FDA, EMA, or ICH experience in your application
Employers sponsoring Regulatory Affairs Managers want evidence you understand the specific regulatory frameworks they operate under. Naming relevant agency experience or submission types you've worked on signals you can contribute immediately and justifies the sponsorship investment.
Apply before the H-1B lottery window closes in March
H-1B registration opens in early March each year. Employers must register by the deadline, and if selected, file by June 30. Regulatory roles often take time to negotiate, so begin conversations with employers at least three to four months before the window opens.
Ask about cap-exempt employers early in the process
Hospitals, nonprofit research institutions, and university-affiliated medical centers are H-1B cap-exempt, meaning they can hire year-round without lottery exposure. Regulatory Affairs roles exist in these settings, particularly in clinical research and academic medical center compliance functions.
Document your regulatory submissions as concrete evidence
When employers assess sponsorship risk, they evaluate whether your contributions justify the cost. A portfolio showing INDs, NDAs, 510(k)s, or CE marking submissions you've led demonstrates measurable specialized expertise that strengthens both the job offer and the H-1B petition.
Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify for H-1B sponsorship?
Yes, Regulatory Affairs Manager is well-established as a specialty occupation for H-1B visa purposes. USCIS consistently recognizes that the role requires at least a bachelor's degree in a specific field such as pharmacy, life sciences, or engineering. Employers in pharma and biotech routinely file and win H-1B petitions for this title, so approval rates are strong when the degree-to-role connection is well-documented.
What degree do I need to get sponsored as a Regulatory Affairs Manager?
A bachelor's degree or higher in pharmacy, biochemistry, biomedical engineering, regulatory science, or a closely related life sciences field is typically required. General science degrees can qualify if your coursework or graduate work directly supports the regulatory function. Some employers also accept degrees in chemistry or microbiology depending on the product type they regulate, such as drugs versus devices.
Which types of employers are most likely to sponsor Regulatory Affairs Managers?
Large pharmaceutical companies, mid-size biotech firms, contract research organizations, and medical device manufacturers are the most active sponsors for this role. These companies have existing immigration infrastructure and legal teams familiar with H-1B filings. Regulatory Affairs functions are core to their FDA compliance obligations, which makes sponsorship a business necessity rather than a discretionary benefit.
Can I find H-1B-sponsoring Regulatory Affairs Manager jobs in one place?
Migrate Mate filters job listings specifically by visa sponsorship, so you can browse Regulatory Affairs Manager roles where employers have indicated they sponsor H-1B and other work visas. This saves significant time compared to screening general job listings manually. The platform is built for international candidates navigating sponsorship, so the roles listed are relevant to your situation by default.
Is E-3 or TN visa sponsorship available for Regulatory Affairs Manager roles?
Australian citizens can pursue Regulatory Affairs Manager positions on the E-3 visa, which also requires a qualifying bachelor's degree and a specialty occupation determination but bypasses the H-1B lottery entirely. Canadian and Mexican citizens may qualify under TN visa status if the role maps to an eligible TN profession. Employers open to H-1B sponsorship are generally also willing to consider E-3 and TN candidates, since the employer-side process is simpler.
What is the prevailing wage requirement for sponsored Regulatory Affairs Manager 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.