H-1B Visa Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialists qualify for H-1B visa sponsorship because the role meets the specialty occupation standard: a bachelor's degree or higher in life sciences, pharmacy, or a related field is typically required. Pharma, biotech, and medical device companies are among the most active H-1B filers for this title.
Find H-1B Visa Regulatory Affairs Specialist JobsOverview
Showing 5 of 268+ Regulatory Affairs Specialist jobs
See all 268+ Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Specialist roles.
Get Access To All JobsRegulatory Affairs Associate
Location: Remote
Contract Duration: 6 months to start
About the Role
We are looking for a Regulatory Affairs Associate to focus on Chemistry, Manufacturing, and Controls (CMC) regulatory submissions and post-approval changes. This role primarily supports CTD Module 3 and selective Module 2 Quality/QOS content for global markets. (Note: While combination product or device work may be involved, pharma CMC experience is strictly mandatory).
Key Responsibilities
- Support and manage post-approval CMC change dossiers for global markets.
- Perform light regulatory authoring and compile submission-ready documents.
- Assist with CTD Module 3 and Module 2 Quality/QOS content.
- Collaborate with internal cross-functional teams and submission managers.
- Manage multiple priorities simultaneously to support global regulatory rollouts.
- Learn and navigate internal EDMS systems quickly to become independently productive within 2–3 months.
Qualifications & Must-Haves
- Experience: 1–2+ years of pharmaceutical/biopharmaceutical regulatory affairs experience with hands-on CMC submission exposure. (Pure medical device/PMA candidates without pharma CMC background will not be considered).
- Education: Bachelor’s degree minimum. A Master’s degree in Regulatory Affairs is acceptable when paired with relevant pharma/CMC co-op or industry experience.
- Technical Knowledge: Working knowledge of CTD/ICH M4Q and Module 3 Quality sections, including understanding where CMC information belongs within the ICH structure.
- Skills: Strong project and time management, excellent written/verbal communication, and comfort working with Electronic Document Management Systems (EDMS).
Preferred Skills
- Experience in post-approval changes and lifecycle management.
- Familiarity with Module 2 Quality/QOS content.
- Prior experience with Veeva Vault, Generis, or similar EDMS/submission platforms.
- Background working with combination products.
Regulatory Affairs Associate
Location: Remote
Contract Duration: 6 months to start
About the Role
We are looking for a Regulatory Affairs Associate to focus on Chemistry, Manufacturing, and Controls (CMC) regulatory submissions and post-approval changes. This role primarily supports CTD Module 3 and selective Module 2 Quality/QOS content for global markets. (Note: While combination product or device work may be involved, pharma CMC experience is strictly mandatory).
Key Responsibilities
- Support and manage post-approval CMC change dossiers for global markets.
- Perform light regulatory authoring and compile submission-ready documents.
- Assist with CTD Module 3 and Module 2 Quality/QOS content.
- Collaborate with internal cross-functional teams and submission managers.
- Manage multiple priorities simultaneously to support global regulatory rollouts.
- Learn and navigate internal EDMS systems quickly to become independently productive within 2–3 months.
Qualifications & Must-Haves
- Experience: 1–2+ years of pharmaceutical/biopharmaceutical regulatory affairs experience with hands-on CMC submission exposure. (Pure medical device/PMA candidates without pharma CMC background will not be considered).
- Education: Bachelor’s degree minimum. A Master’s degree in Regulatory Affairs is acceptable when paired with relevant pharma/CMC co-op or industry experience.
- Technical Knowledge: Working knowledge of CTD/ICH M4Q and Module 3 Quality sections, including understanding where CMC information belongs within the ICH structure.
- Skills: Strong project and time management, excellent written/verbal communication, and comfort working with Electronic Document Management Systems (EDMS).
Preferred Skills
- Experience in post-approval changes and lifecycle management.
- Familiarity with Module 2 Quality/QOS content.
- Prior experience with Veeva Vault, Generis, or similar EDMS/submission platforms.
- Background working with combination products.
See all 268+ H-1B Visa Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Specialist
Align your degree to the role
USCIS requires a direct relationship between your degree field and the job duties. A degree in pharmacy, biochemistry, or regulatory science strengthens your petition. A business or general science degree may trigger an RFE without supporting documentation.
Target LCA-active employers on Migrate Mate
Search Migrate Mate to identify employers who have filed Labor Condition Applications for Regulatory Affairs Specialist roles. This filters for companies with verified H-1B sponsorship history in your specific occupation, not just general sponsorship willingness.
Verify prevailing wage before accepting an offer
Your offered salary must meet the DOL prevailing wage for your job title, industry, and work location. Run the OFLC Wage Search before negotiating to confirm your offer clears the Level I through Level IV wage tiers for your experience.
Document your regulatory credentials upfront
RAC certification, 21 CFR or ICH guideline experience, and submission history for FDA, EMA, or Health Canada all support the specialty occupation argument. Compile these before outreach so employers can assess petition viability early.
Ask about petition timing during interviews
H-1B cap-subject petitions must be filed by April 1 for an October 1 start. If your OPT or grace period ends before October, confirm whether the employer can file for cap-exempt status or structure your start date around the fiscal year cycle.
Cross-reference your SOC code in O*NET
Regulatory Affairs Specialists are classified under SOC 13-1041 or 19-1099 depending on the employer's job description. Confirming the correct SOC code before filing helps ensure the LCA wage level and job duties are accurately matched to your role.
H-1B Visa Regulatory Affairs Specialist: Frequently Asked Questions
Does a Regulatory Affairs Specialist role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS evaluates whether the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs roles tied to FDA submissions, drug approval processes, or device compliance typically meet this standard when the job description specifies a degree in pharmacy, life sciences, or a related discipline. Roles framed as generalist compliance positions may face additional scrutiny.
Which industries sponsor H-1B visas most often for Regulatory Affairs Specialists?
Pharmaceutical manufacturers, biotechnology companies, and medical device firms file the highest volume of H-1B LCAs for this occupation. Contract research organizations and regulatory consulting firms also sponsor, though at lower volumes. You can browse verified H-1B sponsoring employers in this field directly on Migrate Mate, filtered by occupation and filing history.
Can I transfer my H-1B to a new employer if I switch Regulatory Affairs roles?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as they file an H-1B transfer petition, without waiting for approval. The new employer must file a new I-129 with an updated LCA reflecting the new job title, duties, and work location. You don't need to restart the cap count, but the specialty occupation and prevailing wage requirements apply again.
Does my regulatory experience in another country count toward the H-1B specialty occupation requirement?
Foreign work experience can substitute for education under the three-for-one equivalency rule: three years of specialized experience may replace one year of a four-year degree. Experience with international regulatory frameworks like ICH guidelines, EMA submissions, or TGA processes is relevant, but USCIS will expect a credential evaluation from a NACES-recognized agency if your degree or experience is from outside the U.S.
What happens to my H-1B status if my employer's regulatory project ends and I'm laid off?
You have a 60-day grace period from your last day of employment to find a new sponsor, change to another visa status, or depart the U.S. During this window, you can't work but you remain in a valid period of authorized stay. Filing an H-1B transfer with a new employer before the grace period ends is the most common path to continuing work authorization without interruption.