Regulatory Affairs Director Jobs in USA with Visa Sponsorship
Regulatory Affairs Directors are strong H-1B visa sponsorship candidates. The role qualifies as a specialty occupation requiring advanced scientific or regulatory knowledge, and employers routinely sponsor because qualified candidates with FDA, EMA, or ICH experience are difficult to source domestically. 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 Director Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Director roles.
Get Access To All JobsTips for Finding Regulatory Affairs Director Jobs
Lead with your regulatory framework expertise
Employers sponsor when they can't find local talent. Emphasize specific frameworks you've worked within, such as FDA 21 CFR, ICH Q10, or EMA guidelines. Concrete regulatory experience signals you fill a genuine skills gap.
Target companies with active IND or BLA pipelines
Biotech and pharmaceutical companies with live investigational drug or biologics applications have urgent regulatory timelines. They're far more likely to sponsor quickly because regulatory delays cost millions and headcount gaps directly threaten approval schedules.
Highlight cross-border submission experience
Directors who've managed submissions across multiple jurisdictions simultaneously, such as FDA and Health Canada or EMA in parallel, are genuinely rare. This global dossier experience is a concrete reason employers initiate H-1B sponsorship for the right candidate.
Confirm your degree field aligns with the specialty occupation standard
USCIS requires your bachelor's degree or higher to be in a directly related field. Degrees in pharmacy, chemistry, biology, or regulatory science are strong. A business degree alone, without advanced scientific coursework, can complicate the petition.
Engage employers before H-1B lottery season closes
H-1B registrations open in March for an October start date. If you're targeting cap-subject employers, start conversations no later than January so the employer has time to engage immigration counsel and prepare your registration before the window closes.
Ask specifically about cap-exempt employer options
Hospitals, nonprofit research institutions, and universities are cap-exempt, meaning they can file H-1B petitions year-round without lottery risk. Regulatory roles exist in academic medical centers and research hospitals, and these employers often sponsor outside the annual cap.
Frequently Asked Questions
Does a Regulatory Affairs Director role qualify as an H-1B specialty occupation?
Yes, in most cases. USCIS evaluates whether the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs Director roles typically require degrees in pharmacy, life sciences, chemistry, or a related discipline, and the complexity of FDA or EMA regulatory strategy satisfies the specialty occupation standard. Petition strength depends on how the employer's job description is written, so vague requirements can create problems.
How common is H-1B sponsorship for Regulatory Affairs Directors?
Sponsorship is relatively common in pharmaceutical, biotech, and medical device companies because qualified candidates with specific regulatory expertise, particularly in FDA submissions or international dossier management, are difficult to source locally. Mid-size and large companies with established legal infrastructure are the most reliable sponsors. You can browse current openings from sponsoring employers directly on Migrate Mate, which filters specifically for visa-sponsoring companies.
What degree does USCIS expect for a Regulatory Affairs Director H-1B petition?
USCIS looks for a degree in a field directly related to the job duties. Pharmacy, biochemistry, chemistry, biology, regulatory affairs, or a related life science field are strong matches. An MBA or general business degree alone is unlikely to support the petition unless paired with significant graduate-level scientific coursework. Some employers supplement a borderline degree with expert opinion letters from academic professionals attesting to field equivalency.
Can a Regulatory Affairs Director petition qualify for O-1A visa sponsorship instead?
Possibly, for senior directors with a documented record of distinction. The O-1A requires evidence of extraordinary ability, such as peer-reviewed publications, judging industry submissions, authoring regulatory guidance that was adopted, or speaking at major conferences. Directors at the VP level or above who've led landmark drug approvals may have a credible O-1A case. It's worth discussing with an immigration attorney if your H-1B lottery odds are a concern.
Does regulatory affairs experience outside the U.S. count toward H-1B eligibility?
Yes. Foreign regulatory experience, such as managing EMA, TGA, or Health Canada submissions, is directly relevant and strengthens an H-1B petition. USCIS evaluates credentials and experience in the context of the offered position, not where that experience was gained. Foreign degrees may require a credential evaluation by a NACES-member organization to confirm U.S. equivalency, which your employer's immigration attorney will typically arrange as part of the petition process.
What is the prevailing wage requirement for sponsored Regulatory Affairs Director 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.