H-1B Visa Regulatory Affairs Associate Jobs
Regulatory Affairs Associates help pharmaceutical, biotech, and medical device companies secure product approvals from the FDA and international agencies. The role qualifies as a specialty occupation under H-1B visa rules, requiring at least a bachelor's degree in a life sciences, pharmacy, or regulatory field. Many employers in this space have consistent H-1B filing histories.
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Get Access To All JobsResponsibilities:
- Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU
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Create and maintain regulatory records, including:
-
Product registrations
- Approval and renewal updates
- Indication and packaging changes
-
Commitment and obligation tracking
-
Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets
- Monitor submission and approval activities to maintain data integrity and compliance
- Support audit and inspection requests related to regulatory submissions and approvals
- Participate in monthly quality control reviews, identify data gaps, and support remediation efforts
- Assist with system enhancements, upgrades, and continuous process improvement initiatives
Requirements
- Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline
- Experience or exposure to Regulatory Data Management
- Familiarity with Veeva systems
- Strong written and verbal communication skills
- High attention to detail and an interest in global regulatory processes
Whether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment.
Interested or know someone who would be a great fit? Reach out today.
Responsibilities:
- Support regional Regulatory Information Management (RIM) activities using systems such as COSMOS, HUBBLE, and CIU
-
Create and maintain regulatory records, including:
-
Product registrations
- Approval and renewal updates
- Indication and packaging changes
-
Commitment and obligation tracking
-
Partner with global and regional teams to ensure regulatory submissions and correspondence are accurately documented and aligned across markets
- Monitor submission and approval activities to maintain data integrity and compliance
- Support audit and inspection requests related to regulatory submissions and approvals
- Participate in monthly quality control reviews, identify data gaps, and support remediation efforts
- Assist with system enhancements, upgrades, and continuous process improvement initiatives
Requirements
- Bachelor's degree in Regulatory Affairs, Pharmacy, Health Sciences, or a related discipline
- Experience or exposure to Regulatory Data Management
- Familiarity with Veeva systems
- Strong written and verbal communication skills
- High attention to detail and an interest in global regulatory processes
Whether you're a recent graduate or early in your Regulatory Affairs career, this role provides valuable exposure to regulatory operations, global submissions, data governance, and cross-functional collaboration within a highly respected life sciences environment.
Interested or know someone who would be a great fit? Reach out today.
See all 78+ H-1B Visa Regulatory Affairs Associate Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Associate Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Associate
Align your degree to regulatory science
USCIS evaluates whether your degree directly relates to regulatory affairs. A degree in pharmaceutical sciences, chemistry, biology, or a related field strengthens your specialty occupation argument far more than a general science or business credential.
Search LCA filings by SOC code
Regulatory Affairs Associates fall under SOC 13-1041. Use the OFLC Wage Search to filter Labor Condition Applications by that code and identify employers actively certifying wages for this role before you apply.
Target FDA-regulated industries specifically
Pharmaceutical, biologics, and Class II or III medical device companies file H-1B petitions for this role far more consistently than consumer goods or general manufacturing firms. Narrowing your search to these subsectors improves your odds of finding sponsors on Migrate Mate.
Document your product submission experience
When negotiating the offer, provide your employer with a clear summary of your regulatory submissions, such as INDs, NDAs, 510(k)s, or CE marks. This documentation directly supports the employer's specialty occupation argument in the I-129 petition.
Clarify whether the employer uses PERM later
Some regulatory affairs roles are designated as hard-to-fill and qualify for Schedule A, bypassing the PERM labor certification process if you pursue a green card. Ask the hiring team whether they've filed Schedule A petitions for this role before.
Verify employer E-Verify enrollment early
If you're on OPT STEM extension, your employer must be enrolled in E-Verify. Confirm enrollment before accepting an offer. Migrate Mate shows employer verification status alongside LCA filing history so you can check both in one place.
H-1B Visa Regulatory Affairs Associate: Frequently Asked Questions
Does a Regulatory Affairs Associate role qualify as a specialty occupation for H-1B purposes?
Yes, regulatory affairs roles typically qualify because they require specialized knowledge in life sciences, pharmacy, chemistry, or a related field, and employers generally require at least a bachelor's degree in those disciplines. USCIS reviews the job description and the employer's actual hiring practices, so the offer letter and job posting should reflect a specific degree requirement rather than listing a general science background as acceptable.
Which industries sponsor H-1B visas most consistently for this role?
Pharmaceutical companies, biologics manufacturers, and medical device firms that operate under FDA oversight file Labor Condition Applications for this title far more regularly than other sectors. Contract research organizations and regulatory consulting firms also sponsor, though their filing patterns vary. You can filter by industry and occupation code using the OFLC Wage Search or browse employer-verified listings on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA approval or downsizes the regulatory team?
If your employer terminates your position, USCIS provides a 60-day grace period during which you can find a new sponsoring employer. Your new employer must file an H-1B transfer petition before that window closes. Regulatory affairs professionals moving between FDA-regulated companies often qualify for cap-exempt transfers if the new employer is a nonprofit or government research entity.
Does my foreign regulatory experience with EMA or Health Canada count toward H-1B specialty occupation?
Yes, USCIS considers international regulatory experience when evaluating whether a position qualifies as a specialty occupation and whether you meet the qualifications. Experience with EMA submissions, CE marking, or Health Canada approvals demonstrates specialized knowledge that supports the petition. Document that experience in your resume and provide supporting letters from prior employers or clients when your employer files the I-129.
How do I find employers who actively sponsor H-1B visas for Regulatory Affairs Associate roles?
Migrate Mate surfaces employers with verified H-1B LCA filing history filtered to this specific occupation. You can identify pharmaceutical, biotech, and medical device companies that have filed Labor Condition Applications for regulatory roles, confirm their E-Verify enrollment status if you're on OPT, and apply directly through listings that already confirm sponsorship intent.