Regulatory Affairs Analyst Jobs in USA with Visa Sponsorship
Regulatory Affairs Analysts are strong H-1B visa sponsorship candidates. The role qualifies as a specialty occupation requiring a relevant bachelor's degree, and employers in pharma, biotech, and medical devices routinely sponsor both H-1B and green card petitions for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to win in self-care.
DESCRIPTION OVERVIEW
We are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigo's non-medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will contribute to the development and execution of regulatory strategies, helping to deliver high-quality regulatory outcomes across a diverse and dynamic portfolio.
You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities. You will identify regulatory risks, support mitigation activities, and ensure timely, compliant regulatory filings and documentation updates that help maintain supply continuity, consumer safety and market access.
Working both independently and collaboratively, you will manage priorities across multiple activities and projects, ensuring effective delivery and alignment with departmental objectives. You will develop strong partnerships with colleagues across Regulatory Affairs and the wider business to support successful execution of lifecycle initiatives.
Working closely with cross-functional stakeholders, including Quality, Safety, Supply Chain and R&D, you will provide regulatory input to change management activities and business initiatives. You will help translate regulatory requirements into practical actions that support product maintenance, compliance and portfolio optimisation.
You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive greater efficiency, consistency and effectiveness across lifecycle activities. Through your role, you will support Perrigo's ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality.
This role offers the opportunity to make a meaningful contribution within the Regulatory Affairs organisation, supporting product availability and regulatory performance while further developing your regulatory expertise, business knowledge and professional capabilities in a dynamic global environment.
SCOPE OF THE ROLE
- Ensures regulatory compliance of assigned products through independent ownership of lifecycle regulatory activities across multiple products and markets.
- Takes ownership of post-market lifecycle changes, regulatory filings, documentation updates and regulatory issues of moderate to significant complexity, translating requirements into practical, risk-based execution.
- Contributes to both executional and strategic aspects of lifecycle projects and begins to lead workstreams within the LCM remit.
- Independently manages a range of complex product lifecycle changes, regulatory filings, notifications, registrations and documentation updates across products and markets.
- Works mostly independently end-to-end, seeking alignment for high-risk decisions and providing risk-based recommendations within delegated authority.
- Leads workstreams and begins project leadership; impact spans multiple products or markets with material delivery and compliance implications.
- As part of this role you may have the opportunity to work on other classifications in the non-medicinal area such as medical devices where needed based on business requirements.
LIFECYCLE STRATEGY & CHANGE ASSESSMENT
- Independently assess and manage a range of complex post-market lifecycle changes, working with cross-functional teams and authorities where needed to identify data requirements and update regulatory documentation and product files.
- Determine regulatory pathway or classification for complex changes within scope and provide clear rationale and risk-based recommendations.
- Maintain regulatory intelligence and proactively manage the impact of regulatory changes, informing relevant stakeholders of developments affecting the existing portfolio.
SUBMISSION DELIVERY & COMPLIANCE EXECUTION
- Establish, maintain, review, approve, and update product information files, technical files, regulatory records and supporting documentation in compliance with applicable legislation.
- Manage central notifications, registration filings, renewals, documentation updates or related regulatory procedures across products; prepare files, answer RFIs, and manage timelines.
- Develop and approve updated master labels and support implementation readiness and traceability to approvals.
- Support audits and CAPA reporting or follow-up as necessary and mitigate risks to avoid supply disruption.
STAKEHOLDER LEADERSHIP & IMPROVEMENT
- Represent Regulatory in project teams and cross-functional forums and manage stakeholder communication on requirements, risks, and proposals.
- Support Cluster RA authority communication and respond to queries as necessary for lifecycle topics.
- Identify, suggest, and execute improvements to processes and ways of working within and across functions to improve quality and predictability of lifecycle delivery.
- Ensure robust handover and transition of product information files, technical documentation, regulatory decisions, and implementation requirements at launch and through post-market lifecycle changes.
EXPERIENCE REQUIRED
- Typically 3–5 years in Regulatory Affairs; relevant scientific or technical degree preferred.
- Ability to represent Regulatory in project teams and lead defined workstreams with increasing independence.
- Practical experience across lifecycle submissions, dossier maintenance, and cross-functional issue resolution.
BENEFITS
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo.
HYBRID WORKING APPROACH
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here.
APPLICANTS PLEASE NOTE:
To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.
We are 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 other characteristics protected by law. #weareperrigo
INTRODUCTION
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to win in self-care.
DESCRIPTION OVERVIEW
We are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigo's non-medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will contribute to the development and execution of regulatory strategies, helping to deliver high-quality regulatory outcomes across a diverse and dynamic portfolio.
You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities. You will identify regulatory risks, support mitigation activities, and ensure timely, compliant regulatory filings and documentation updates that help maintain supply continuity, consumer safety and market access.
Working both independently and collaboratively, you will manage priorities across multiple activities and projects, ensuring effective delivery and alignment with departmental objectives. You will develop strong partnerships with colleagues across Regulatory Affairs and the wider business to support successful execution of lifecycle initiatives.
Working closely with cross-functional stakeholders, including Quality, Safety, Supply Chain and R&D, you will provide regulatory input to change management activities and business initiatives. You will help translate regulatory requirements into practical actions that support product maintenance, compliance and portfolio optimisation.
You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive greater efficiency, consistency and effectiveness across lifecycle activities. Through your role, you will support Perrigo's ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality.
This role offers the opportunity to make a meaningful contribution within the Regulatory Affairs organisation, supporting product availability and regulatory performance while further developing your regulatory expertise, business knowledge and professional capabilities in a dynamic global environment.
SCOPE OF THE ROLE
- Ensures regulatory compliance of assigned products through independent ownership of lifecycle regulatory activities across multiple products and markets.
- Takes ownership of post-market lifecycle changes, regulatory filings, documentation updates and regulatory issues of moderate to significant complexity, translating requirements into practical, risk-based execution.
- Contributes to both executional and strategic aspects of lifecycle projects and begins to lead workstreams within the LCM remit.
- Independently manages a range of complex product lifecycle changes, regulatory filings, notifications, registrations and documentation updates across products and markets.
- Works mostly independently end-to-end, seeking alignment for high-risk decisions and providing risk-based recommendations within delegated authority.
- Leads workstreams and begins project leadership; impact spans multiple products or markets with material delivery and compliance implications.
- As part of this role you may have the opportunity to work on other classifications in the non-medicinal area such as medical devices where needed based on business requirements.
LIFECYCLE STRATEGY & CHANGE ASSESSMENT
- Independently assess and manage a range of complex post-market lifecycle changes, working with cross-functional teams and authorities where needed to identify data requirements and update regulatory documentation and product files.
- Determine regulatory pathway or classification for complex changes within scope and provide clear rationale and risk-based recommendations.
- Maintain regulatory intelligence and proactively manage the impact of regulatory changes, informing relevant stakeholders of developments affecting the existing portfolio.
SUBMISSION DELIVERY & COMPLIANCE EXECUTION
- Establish, maintain, review, approve, and update product information files, technical files, regulatory records and supporting documentation in compliance with applicable legislation.
- Manage central notifications, registration filings, renewals, documentation updates or related regulatory procedures across products; prepare files, answer RFIs, and manage timelines.
- Develop and approve updated master labels and support implementation readiness and traceability to approvals.
- Support audits and CAPA reporting or follow-up as necessary and mitigate risks to avoid supply disruption.
STAKEHOLDER LEADERSHIP & IMPROVEMENT
- Represent Regulatory in project teams and cross-functional forums and manage stakeholder communication on requirements, risks, and proposals.
- Support Cluster RA authority communication and respond to queries as necessary for lifecycle topics.
- Identify, suggest, and execute improvements to processes and ways of working within and across functions to improve quality and predictability of lifecycle delivery.
- Ensure robust handover and transition of product information files, technical documentation, regulatory decisions, and implementation requirements at launch and through post-market lifecycle changes.
EXPERIENCE REQUIRED
- Typically 3–5 years in Regulatory Affairs; relevant scientific or technical degree preferred.
- Ability to represent Regulatory in project teams and lead defined workstreams with increasing independence.
- Practical experience across lifecycle submissions, dossier maintenance, and cross-functional issue resolution.
BENEFITS
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo.
HYBRID WORKING APPROACH
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here.
APPLICANTS PLEASE NOTE:
To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.
We are 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 other characteristics protected by law. #weareperrigo
See all 1,248+ Regulatory Affairs Analyst Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Analyst roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Analyst
Target regulated industries with established sponsorship pipelines
Pharmaceutical, biotechnology, and medical device companies file H-1B petitions for Regulatory Affairs Analysts at high rates. These industries have dedicated immigration budgets and HR teams experienced with the sponsorship process, making them significantly more receptive than general employers.
Match your degree field to the role's regulatory discipline
USCIS requires your degree to align with the specific regulatory domain. Life sciences, chemistry, pharmacy, biomedical engineering, or regulatory science degrees support most petitions. A business degree alone rarely satisfies the specialty occupation standard for this role without additional credentials.
Document your technical expertise in regulatory frameworks
Employers filing your H-1B petition need to demonstrate the role requires specialized knowledge. Highlight specific experience with FDA submissions, EU MDR, ICH guidelines, or 21 CFR compliance. Generic quality or compliance backgrounds are harder to support than documented regulatory specialization.
Understand that company size affects sponsorship willingness
Large pharma and medical device companies sponsor Regulatory Affairs roles routinely. Smaller biotech startups may be willing but lack internal immigration infrastructure. Confirm early whether the company has sponsored before and whether they use outside immigration counsel for H-1B filings.
Position yourself for EB-2 or EB-3 early in the H-1B process
Regulatory Affairs roles at mid-to-senior levels often support EB-2 green card petitions, especially if the work requires advanced degree knowledge. Ask employers upfront whether they support green card sponsorship alongside the H-1B, as timelines vary significantly by country of birth.
Australian citizens should evaluate the E-3 visa as an H-1B alternative
The E-3 visa covers Regulatory Affairs Analyst roles and has no lottery, no annual cap pressure, and faster processing than the H-1B. If you hold Australian citizenship and have a qualifying degree, E-3 sponsorship is often easier for employers to commit to than H-1B.
Frequently Asked Questions
Does a Regulatory Affairs Analyst role qualify for H-1B sponsorship?
Yes, Regulatory Affairs Analyst is widely recognized as a specialty occupation for H-1B purposes. USCIS expects a bachelor's degree or higher in a field directly related to the regulatory work, such as life sciences, pharmacy, biomedical engineering, or regulatory science. Petitions supported by a general business or unrelated degree face higher RFE risk, particularly at the analyst level where USCIS scrutinizes whether the degree requirement is genuinely specific to the role.
Which industries sponsor Regulatory Affairs Analysts most frequently?
Pharmaceutical, biotechnology, and medical device companies account for the large majority of H-1B sponsorships for this role, based on Department of Labor LCA disclosure data. Contract research organizations and regulatory consulting firms also sponsor regularly. Government contractors and consumer goods companies with regulated product lines occasionally sponsor, but at much lower rates. Browse current openings filtered by sponsorship willingness on Migrate Mate to identify active employers in these sectors.
What degree do I need for an employer to sponsor my H-1B as a Regulatory Affairs Analyst?
A bachelor's degree in a field directly tied to the regulatory domain is the baseline requirement. Life sciences, chemistry, biochemistry, pharmacy, biomedical engineering, and regulatory affairs-specific programs are the strongest fits. USCIS applies the specialty occupation standard strictly, so a degree in a related but tangential field should be supported by relevant coursework or postgraduate credentials. Some roles at the senior level accept an advanced degree in lieu of direct field alignment.
How strong is H-1B approval for Regulatory Affairs Analyst petitions?
Approval rates for this role are generally solid when the petition is well-documented and the degree field aligns with the regulatory specialty. The most common issue leading to Requests for Evidence is insufficient documentation that the job requires a specific degree rather than any bachelor's degree. Employers with experienced immigration counsel and a history of sponsoring this role category tend to have significantly better petition outcomes than first-time sponsors filing without legal support.
Can I get sponsored as a Regulatory Affairs Analyst on a visa other than the H-1B?
Australian citizens qualify for the E-3 visa, which covers this role and avoids the H-1B lottery entirely. Canadian and Mexican nationals may qualify under TN visa status in certain regulatory categories, though the fit depends on specific job duties and degree. O-1A visa sponsorship is possible for candidates with documented recognition in regulatory affairs, such as publications, speaking engagements, or leadership in professional organizations, though this is less common at the analyst level.
What is the prevailing wage requirement for sponsored Regulatory Affairs Analyst 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.