Regulatory Affairs Associate Jobs in USA with Visa Sponsorship
Regulatory Affairs Associates working in pharmaceuticals, medical devices, and biotech regularly receive H-1B visa and O-1 visa sponsorship. The role qualifies as a specialty occupation requiring a bachelor's degree or higher in a scientific or regulatory field, making employer sponsorship straightforward for qualified candidates. 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 872+ Regulatory Affairs Associate Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Associate roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Associate
Target FDA-regulated industries first
Pharmaceutical, biotech, and medical device companies have established immigration programs and sponsor Regulatory Affairs Associates at higher rates than other sectors. These employers file LCAs and H-1B petitions routinely, which means faster internal approval processes for sponsorship requests.
Document your degree's relevance to the role
USCIS requires a direct relationship between your degree field and the job duties. Degrees in life sciences, chemistry, pharmacology, or biomedical engineering map cleanly. If your degree is adjacent, gather course transcripts that demonstrate regulatory, scientific, or compliance coursework.
Highlight submission experience in your resume
Employers sponsoring H-1B petitions need to prove the role requires specialized knowledge. Listing specific submissions, such as 510(k)s, INDs, or CTAs, strengthens both your candidacy and the specialty occupation argument USCIS evaluates during petition review.
Apply to companies with existing RAA headcount
Companies that already employ Regulatory Affairs Associates on H-1B status have proven their HR and legal teams can handle the process. Joining an established regulatory department significantly reduces friction compared to being the first sponsored employee in that function.
Understand the H-1B lottery timing before accepting offers
If you need cap-subject H-1B sponsorship, registration opens in March for an October 1 start. Clarify your current status and timeline with each employer early in interviews so both parties understand what bridging arrangements, such as OPT extension, may be needed.
Consider contract and CRO roles as entry points
Contract Research Organizations and staffing agencies that place regulatory professionals often sponsor visas and can be faster to move than large pharma legal teams. A contract role with sponsorship builds U.S. regulatory experience that strengthens future full-time petitions.
Frequently Asked Questions
Does a Regulatory Affairs Associate role qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Associate positions consistently qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in a specific scientific or regulatory field, life sciences, chemistry, biomedical engineering, or pharmacy are the most common. USCIS has approved thousands of H-1B petitions for this job title across pharmaceutical and medical device companies. The role's technical complexity and degree requirement make denial on specialty occupation grounds uncommon when the petition is properly documented.
Which visa types do Regulatory Affairs Associates most commonly receive sponsorship for?
H-1B is the most common visa for Regulatory Affairs Associates. Candidates with extraordinary achievement in regulatory science, such as published research or leadership on major submissions, sometimes qualify for O-1A. Australians with the right credentials should explore the E-3 visa, which skips the H-1B lottery entirely and is easier for employers to process. Use Migrate Mate to filter job listings by visa type and identify which sponsoring employers are actively hiring.
Do employers in pharma and biotech routinely sponsor Regulatory Affairs Associates?
Yes, sponsorship rates are high in this field. Large pharmaceutical companies, mid-size biotechs, and medical device manufacturers all hire internationally and have immigration counsel on retainer. DOL LCA disclosure data consistently shows companies like Johnson & Johnson, Pfizer, and Abbott filing for Regulatory Affairs roles. Smaller companies and startups sponsor less predictably, so it is worth confirming sponsorship willingness early in the interview process.
Can I qualify for Regulatory Affairs Associate sponsorship with a non-science degree?
It depends on the specific degree and how closely it relates to the regulatory function. A degree in public health, law, or even engineering can support a petition if your coursework or professional experience maps to regulatory compliance. USCIS evaluates whether the degree is in a directly related field. A credential evaluation and a strong job description tying your background to regulatory requirements will be necessary. An immigration attorney can assess your specific profile before you apply.
What documents does my employer need to sponsor my H-1B as a Regulatory Affairs Associate?
Your employer needs to file a Labor Condition Application with the Department of Labor, then submit Form I-129 to USCIS with supporting documentation. That includes a detailed job description outlining the regulatory duties and degree requirements, proof of your qualifications, and evidence the employer can pay the prevailing wage. For Regulatory Affairs roles, employers often include examples of the regulatory submissions the position manages to strengthen the specialty occupation argument.
What is the prevailing wage requirement for sponsored Regulatory Affairs Associate 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.