Senior Director Regulatory Affairs Jobs in USA with Visa Sponsorship
Senior Director Regulatory Affairs roles are sponsored under the H-1B visa, requiring an advanced degree in a scientific or regulatory field. Employers file a Labor Condition Application and I-129 petition on your behalf. Most positions are with pharmaceutical, biotech, or medical device companies that sponsor regularly. 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 2,601+ Senior Director Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Senior Director Regulatory Affairs roles.
Get Access To All JobsTips for Finding Senior Director Regulatory Affairs Jobs
Target established life sciences companies
Large pharmaceutical, biotech, and medical device companies have dedicated immigration teams and sponsor H-1B visas routinely. Smaller startups may lack the infrastructure to navigate USCIS petitions for senior regulatory roles, making established employers a safer bet.
Emphasize your degree field, not just your title
H-1B specialty occupation requires a degree directly related to the role. A master's or PhD in regulatory affairs, pharmacy, chemistry, or a life sciences discipline strengthens your petition significantly over a general business or unrelated STEM degree.
Highlight FDA, EMA, or ICH regulatory experience
Senior Director roles require demonstrable leadership across submissions, IND, NDA, or 510(k) filings. Employers sponsoring at this level need to justify the position's complexity to USCIS, so your track record with major regulatory agencies directly supports their petition.
Negotiate sponsorship before accepting an offer
At the Senior Director level, visa sponsorship is often negotiable. Raise the topic explicitly during offer discussions, not after signing. Confirm the employer will cover legal fees and premium processing, which significantly reduces your H-1B approval timeline.
Get clarity on cap-exempt employer status
Universities, nonprofit research institutions, and certain government-affiliated organizations are exempt from the H-1B annual cap and lottery. If a Senior Director role exists at a cap-exempt employer, you can apply year-round without waiting for the April lottery window.
Prepare detailed documentation of your regulatory leadership scope
USCIS scrutinizes senior-level H-1B petitions for specialty occupation qualification. Provide organizational charts, descriptions of your direct reports, and evidence of cross-functional regulatory strategy responsibilities. Vague job descriptions increase the likelihood of a Request for Evidence.
Frequently Asked Questions
Can a Senior Director of Regulatory Affairs get H-1B sponsorship?
Yes. Senior Director Regulatory Affairs roles qualify as H-1B visa specialty occupations because they typically require at least a bachelor's degree in a specific scientific or regulatory field. Most employers in pharma, biotech, and medical devices sponsor this title regularly. At the senior director level, petitions generally have strong approval rates when the degree-to-role connection is clearly documented.
What degree do I need for H-1B sponsorship in this role?
A bachelor's degree at minimum is required, but most employers sponsoring at the Senior Director level expect a master's degree or PhD in pharmacy, chemistry, biology, regulatory science, or a closely related discipline. A general business degree alone is unlikely to satisfy USCIS specialty occupation requirements unless paired with substantial relevant coursework or a combination of education and experience.
How do I find companies actively sponsoring Senior Director Regulatory Affairs roles?
Migrate Mate filters job listings specifically for visa-sponsoring employers, making it the most efficient way to identify companies actively hiring at this level with H-1B support. Look for large pharmaceutical companies, contract research organizations, and established medical device manufacturers, as these categories file H-1B petitions for regulatory leadership roles most consistently.
Will USCIS issue a Request for Evidence for a Senior Director H-1B petition?
RFEs are more common for senior-level petitions because USCIS sometimes questions whether a director-level title truly requires a specific degree rather than broad management experience. The strongest petitions include detailed position descriptions, the organizational hierarchy, evidence of technical regulatory duties, and documentation that the role cannot be performed without specialized academic training in the field.
Can I transfer my H-1B to a new employer as a Senior Director?
Yes. H-1B portability allows you to start working for a new employer as soon as the transfer petition is filed, without waiting for approval, provided you're maintaining valid status. Your new employer files a fresh I-129. At the Senior Director level, ensure your new employer is prepared to document specialty occupation requirements thoroughly, as USCIS reviews transfer petitions with the same scrutiny as initial filings.
What is the prevailing wage requirement for sponsored Senior Director Regulatory Affairs 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.