H-1B Visa Regulatory Affairs Manager Jobs
Regulatory Affairs Managers qualify for H-1B visa sponsorship as a specialty occupation requiring a bachelor's degree or higher in a directly related field such as regulatory science, pharmacy, or life sciences. Pharma, biotech, and medical device companies sponsor heavily for this role, and the work spans FDA submissions, compliance strategy, and cross-functional product approvals.
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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 Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Manager Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Manager
Align your credentials to specialty occupation requirements
USCIS evaluates whether your degree field directly relates to regulatory affairs work. A degree in regulatory science, pharmacy, chemistry, or biomedical engineering strengthens your petition far more than a general business degree, even with years of relevant experience.
Target employers with active LCA filing history
Search Migrate Mate to filter Regulatory Affairs Manager roles by employers who have filed Labor Condition Applications for this occupation. LCA history confirms an employer has already navigated DOL prevailing wage requirements for your exact job category.
Verify your role's SOC code before accepting an offer
Regulatory Affairs Managers are typically classified under SOC 11-9199 or 11-1021 depending on the employer. The SOC code determines the prevailing wage tier DOL uses, so confirm your employer's classification matches your actual duties before the LCA is filed.
Ask about cap-exempt employer status during interviews
Hospitals, universities, and certain nonprofit research institutions attached to higher education can sponsor H-1B visas outside the annual lottery cap. Regulatory affairs roles at academic medical centers or NIH-affiliated labs may let you skip the lottery entirely.
Use O*NET to document specialty occupation evidence
O*NET lists the typical education and knowledge requirements for regulatory affairs occupations. Print or save this profile before your petition is filed. Employers and attorneys use it to demonstrate that a bachelor's in a specific field is standard for the role.
Request premium processing if product timelines are tight
Regulatory affairs roles often tie directly to product launch or FDA submission deadlines. USCIS premium processing adjudicates the I-129 petition within 15 business days. Ask your employer to include it if your start date aligns with a critical regulatory milestone.
H-1B Visa Regulatory Affairs Manager: Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS recognizes Regulatory Affairs Manager as a specialty occupation because the role typically requires a bachelor's degree or higher in a field such as regulatory science, pharmacy, chemistry, or a related life sciences discipline. Employers must document in the LCA and I-129 petition that the position demands specialized theoretical and practical knowledge tied to a specific degree field.
Which industries sponsor H-1B visas most consistently for Regulatory Affairs Managers?
Pharmaceutical, biotechnology, and medical device companies account for the largest share of H-1B sponsorships for this role, driven by FDA submission requirements and ongoing compliance obligations. Contract research organizations and in vitro diagnostics firms also sponsor regularly. You can browse verified sponsoring employers filtered by this job title on Migrate Mate.
How does the prevailing wage requirement affect Regulatory Affairs Manager H-1B filings?
Your employer must pay at least the DOL prevailing wage for a Regulatory Affairs Manager in the specific metropolitan area where you'll work. Wages are tiered by experience level, and the employer certifies this on the LCA before filing the H-1B petition. You can look up applicable wage levels by location and SOC code using the OFLC Wage Search.
Can a Regulatory Affairs Manager change employers while on H-1B status?
Yes, through H-1B portability under AC21. Once your initial H-1B petition has been approved and you've worked for the sponsoring employer, a new employer can file an H-1B transfer petition and you can begin work as soon as the receipt notice is issued. The new role must still qualify as a specialty occupation in regulatory affairs.
What documentation strengthens an H-1B petition for a Regulatory Affairs Manager role?
Strong petitions include a detailed job description specifying FDA regulatory submissions, compliance programs, or device approval processes; official transcripts showing a degree in a relevant field; and an employer letter explaining why the position requires that specific degree. If your title varies by employer, the O*NET occupation profile for this role category can serve as supporting evidence of degree-level requirements.