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.
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Get Access To All JobsWork Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a typical Monday to Friday work schedule. The ability to work in-office in Austin, TX is required for 50% of the time.
Discover Impactful Work
Join us to help build the future of science and healthcare by ensuring regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
A day in the Life
- Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.
- Engage regulators in oral and written communications to discuss submissions, requirements, and address questions.
- Serve as RA subject matter expert, staying current on Animal Health regulations, guidance documents, notices, and competitor news.
- Coordinate regulatory issue resolution using internal resources, agencies, and outside consultants.
- Conduct trainings and communicate materials to enhance team knowledge of regulated environments.
- Review and approve labeling, packaging, advertising, and promotional materials for regulatory compliance.
- Participate in business meetings with internal collaborators and external partners.
- Collaborate with global regulatory professionals, providing guidance on strategies, submissions, and projects.
Keys to Success
Education
Bachelor’s degree in life sciences, bio-engineering or related science required.
Experience
- 2+ years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as well as US IVD and CE-IVD experience required.
- Experience working with USDA regulations required.
- Demonstrated ability to maintain regulatory permits and licenses.
- Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.
Knowledge, Skills, Abilities
- Experience in regulatory affairs, including strategy creation and development control.
- Outstanding attention to detail and time management skills.
- Excellent interpersonal, customer orientation, and presentation skills.
- Provided regulatory guidance on project teams.
- Detail-oriented for regulatory reviews.
- Skilled in multi-tasking and business impact.
- Effective in matrixed environments and conflict resolution.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a typical Monday to Friday work schedule. The ability to work in-office in Austin, TX is required for 50% of the time.
Discover Impactful Work
Join us to help build the future of science and healthcare by ensuring regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
A day in the Life
- Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.
- Engage regulators in oral and written communications to discuss submissions, requirements, and address questions.
- Serve as RA subject matter expert, staying current on Animal Health regulations, guidance documents, notices, and competitor news.
- Coordinate regulatory issue resolution using internal resources, agencies, and outside consultants.
- Conduct trainings and communicate materials to enhance team knowledge of regulated environments.
- Review and approve labeling, packaging, advertising, and promotional materials for regulatory compliance.
- Participate in business meetings with internal collaborators and external partners.
- Collaborate with global regulatory professionals, providing guidance on strategies, submissions, and projects.
Keys to Success
Education
Bachelor’s degree in life sciences, bio-engineering or related science required.
Experience
- 2+ years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as well as US IVD and CE-IVD experience required.
- Experience working with USDA regulations required.
- Demonstrated ability to maintain regulatory permits and licenses.
- Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.
Knowledge, Skills, Abilities
- Experience in regulatory affairs, including strategy creation and development control.
- Outstanding attention to detail and time management skills.
- Excellent interpersonal, customer orientation, and presentation skills.
- Provided regulatory guidance on project teams.
- Detail-oriented for regulatory reviews.
- Skilled in multi-tasking and business impact.
- Effective in matrixed environments and conflict resolution.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
See all 80+ H-1B Visa Regulatory Affairs Specialist Jobs
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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.