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.
Find Regulatory Affairs Specialist JobsOverview
Showing 5 of 872+ Regulatory Affairs Specialist jobs
See all 872+ Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Specialist roles.
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 872+ Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Specialist roles.
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.