OPT Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialist roles are a strong fit for F-1 OPT students with degrees in life sciences, pharmacy, chemistry, or engineering. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in pharma, biotech, and medical devices regularly sponsor H-1B visas for this role.
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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 54+ OPT Regulatory Affairs Specialist Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship as a Regulatory Affairs Specialist
Target regulated industries first
Pharma, biotech, and medical device companies have dedicated regulatory departments and are accustomed to visa sponsorship. These employers file H-1B petitions regularly, making them far more likely to extend your OPT into full sponsorship than general employers.
Confirm your degree qualifies for STEM OPT
Regulatory Affairs roles typically qualify for the 24-month STEM OPT extension if your degree is in biology, chemistry, pharmacy, or a related field. Verify your CIP code with your DSO before applying so you know your full authorization window upfront.
Highlight regulatory database experience on your resume
Familiarity with FDA submission systems, eCTD formatting, or ICH guidelines signals job-readiness to hiring managers. Specific technical knowledge reduces employer hesitation about the time investment required to train an OPT hire before sponsorship becomes relevant.
Ask about H-1B sponsorship before accepting an offer
Regulatory Affairs positions are specialty occupations that meet H-1B criteria, but not every employer actively sponsors. Confirm willingness to sponsor during the offer stage, not after you've started, so you can plan your immigration timeline without surprises.
Apply early relative to your OPT end date
H-1B cap-subject petitions must be filed in April for an October 1 start. If your OPT expires before October, your employer may need to request a cap-gap extension. Start your job search at least six months before your OPT authorization ends.
Pursue RAC or RAPS certification if you're early career
The Regulatory Affairs Certification from RAPS signals credibility in a field where credentials matter. Even pursuing coursework demonstrates commitment to the profession, which can reassure employers considering the additional overhead of sponsoring a work visa.
Regulatory Affairs Specialist OPT: Frequently Asked Questions
Does a Regulatory Affairs Specialist role qualify for the STEM OPT extension?
Yes, in most cases. If your undergraduate or graduate degree is in a STEM field such as biology, chemistry, pharmaceutical sciences, or biomedical engineering, your role will typically qualify for the 24-month STEM OPT extension. Confirm your degree's CIP code with your DSO, since the extension is tied to your degree classification, not the job title itself.
Is Regulatory Affairs Specialist considered a specialty occupation for H-1B purposes?
Yes. Regulatory Affairs Specialist positions generally qualify as specialty occupations under H-1B rules because they require at minimum a bachelor's degree in a specific field such as life sciences, chemistry, or pharmacy. USCIS has consistently approved H-1B petitions for this role when the degree requirement is clearly documented in the job description and employer attestation.
Which types of employers are most likely to sponsor OPT students in regulatory affairs?
Pharmaceutical companies, biotechnology firms, medical device manufacturers, and contract research organizations are the most active sponsors for this role. These companies operate under FDA oversight and maintain in-house regulatory teams that file H-1B petitions routinely. You can browse OPT-friendly regulatory affairs openings directly on Migrate Mate, which filters for employers open to sponsorship.
What happens if my OPT expires before the H-1B October 1 start date?
If your employer files an H-1B petition on your behalf before your OPT expires, you're covered by cap-gap protection, which automatically extends your work authorization through September 30. Your employer must file before your OPT end date for cap-gap to apply. Work with your DSO and employer's immigration counsel to confirm the filing timeline well in advance.
Do I need to disclose my OPT status when applying for Regulatory Affairs roles?
You don't have to disclose it upfront in your application, but employers will ask about work authorization status before extending an offer. Being prepared to explain your OPT timeline, STEM extension eligibility, and H-1B sponsorship needs clearly and confidently tends to reduce employer hesitation. Framing your remaining authorization window accurately helps employers assess whether the timeline works for their hiring plans.