H-1B Visa Regulatory Affairs Jobs
Regulatory Affairs roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in life sciences, pharmacy, or a related technical field. Employers in pharma, biotech, and medical devices file LCAs with the DOL before sponsoring, and many actively recruit internationally trained RA professionals.
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Get Access To All JobsJob Overview:
Line Management responsibilities for a Regulatory Affairs site or combination of sites.
Essential Functions:
- Manage staff in accordance with organization’s policies and applicable regulations; Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; Approve actions on human resources matters, including salary administration;
- Effectively manages the team's resources and delegates tasks commensurate with skill level; Evaluates workload, quality and metrics through regular review and reporting of findings;
- Effectively collaborate with operational colleagues to manage project- and team-related challenges;
- Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate;
- Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives; Leads strategic initiatives and develops implementation plans;
- Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites;
- Undertakes risk analysis and manages the outcome as appropriate;
- May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations;
- May provide strategic regulatory and/or technical consultancy on a variety of projects;
- Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA;
- May take leadership role in bid defense strategy and planning;
- May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience;
Qualifications:
- Bachelor's Degree in Lifescience or related discipline Req Or
- Master's Degree in Lifescience or related discipline
- At least 8 years regulatory experience including 6 years management experience
- Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
- Line management experience required, with demonstrated success in development, engagement and performance of senior staff
- Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers and staff
- Possesses an acute awareness of issues outwith the business function. Exudes confidence and authority within remit, and delivers a positive example to teams
- Communicates an inspiring vision of the Regulatory Strategic Plan and helps others understand and value their role in it.
- Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations
- Sound financial awareness
- Strong software and computer skills, including MS Office applications
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
Compensation
- The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Location:
Home-based
You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.
Culture
Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Job Overview:
Line Management responsibilities for a Regulatory Affairs site or combination of sites.
Essential Functions:
- Manage staff in accordance with organization’s policies and applicable regulations; Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; Approve actions on human resources matters, including salary administration;
- Effectively manages the team's resources and delegates tasks commensurate with skill level; Evaluates workload, quality and metrics through regular review and reporting of findings;
- Effectively collaborate with operational colleagues to manage project- and team-related challenges;
- Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate;
- Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives; Leads strategic initiatives and develops implementation plans;
- Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites;
- Undertakes risk analysis and manages the outcome as appropriate;
- May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations;
- May provide strategic regulatory and/or technical consultancy on a variety of projects;
- Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA;
- May take leadership role in bid defense strategy and planning;
- May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience;
Qualifications:
- Bachelor's Degree in Lifescience or related discipline Req Or
- Master's Degree in Lifescience or related discipline
- At least 8 years regulatory experience including 6 years management experience
- Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff
- Line management experience required, with demonstrated success in development, engagement and performance of senior staff
- Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers and staff
- Possesses an acute awareness of issues outwith the business function. Exudes confidence and authority within remit, and delivers a positive example to teams
- Communicates an inspiring vision of the Regulatory Strategic Plan and helps others understand and value their role in it.
- Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations
- Sound financial awareness
- Strong software and computer skills, including MS Office applications
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
Compensation
- The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Location:
Home-based
You’ll work remotely, with the flexibility to do your best work from home. Supported by collaborative tools and a global team, you’ll stay connected while enjoying the autonomy and balance that comes with a fully remote role.
Culture
Culture at IQVIA is built on a shared belief: that when people are empowered with better data, smarter technology and deeper expertise, they can change what’s possible for patients. Across every team and every corner of the globe, you’ll find colleagues who genuinely care — about the mission and about each other. That’s what makes this a place where people tend to stay, grow and do the best work of their careers.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
See all 229+ H-1B Visa Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs
Align your degree to FDA submission work
USCIS scrutinizes whether your degree field directly supports the specific RA duties in the job description. A chemistry or biology degree paired with regulatory coursework strengthens specialty occupation arguments far more than a general science background.
Search LCA filings before applying anywhere
Use Migrate Mate to filter employers by verified DOL LCA filing history in Regulatory Affairs. This surfaces companies that have already demonstrated H-1B sponsorship intent for this job code, cutting your search time significantly.
Target employers with dedicated RA departments
Standalone RA departments at mid-size pharma and Class II medical device companies sponsor more consistently than generalist consulting firms. O*NET classifies Regulatory Affairs Specialists under SOC 13-1041, which you can cross-reference against OFLC disclosure data.
Negotiate LCA filing into your offer timeline
The DOL must certify your LCA before USCIS receives the I-129 petition. Ask your employer to begin the LCA at least three weeks before your intended start date so certification doesn't delay your H-1B effective date.
Document foreign regulatory experience for RFEs
If you've worked with EMA, Health Canada, or TGA submissions, get official employer letters specifying submission types and your exact role. USCIS RFEs on RA petitions frequently challenge whether non-U.S. experience maps to the specialty occupation standard.
Verify your employer's E-Verify enrollment status
H-1B employers must be E-Verify participants to request cap-exempt processing through certain institutions or to rehire H-1B workers portably. Confirm enrollment before your final offer acceptance, not after signing.
H-1B Visa Regulatory Affairs: Frequently Asked Questions
Does a Regulatory Affairs job qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Specialist roles require theoretical and practical application of life sciences, pharmacy, chemistry, or engineering knowledge at the bachelor's degree level or higher. USCIS has approved H-1B petitions for RA roles across pharma, biotech, and medical device sectors. The employer's job description must specify degree requirements that are directly related to RA duties, not just broadly preferred.
Which industries sponsor H-1B visas most often for Regulatory Affairs professionals?
Pharmaceutical manufacturers, biologics companies, Class II and Class III medical device firms, and CROs file the largest volume of H-1B LCAs for Regulatory Affairs roles. Biotech startups preparing for IND or NDA submissions also sponsor frequently because RA expertise is scarce domestically. You can browse employers with active H-1B filing history for this role category on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA contract or restructures the RA team?
You have a 60-day grace period after involuntary termination to find new H-1B sponsorship, change to another status, or depart the U.S. Under AC21 portability rules, if your I-140 has been approved and your I-485 has been pending for 180 days or more, you can port to a same or similar RA role with a new employer without losing your priority date.
How does the prevailing wage requirement affect H-1B sponsorship for Regulatory Affairs roles?
Your employer must pay at least the DOL prevailing wage for the RA job title, level, and work location. Prevailing wages are set at four wage levels based on experience and complexity. You can look up the applicable wage yourself using the OFLC Wage Search before negotiations. Employers who underpay relative to the certified LCA wage risk DOL audit and back-pay liability.
Can I transfer my H-1B to a new Regulatory Affairs employer mid-sponsorship?
Yes. H-1B portability lets you start working for a new H-1B employer as soon as the new I-129 petition is filed, not after approval. The new role must be in the same or a substantially similar RA occupational classification. Your new employer files a new LCA and I-129; you don't restart the lottery. This makes lateral moves within RA feasible without status gaps.