OPT Regulatory Affairs Jobs
Regulatory Affairs jobs are a strong fit for OPT students with degrees in pharmacy, biology, chemistry, or engineering. Most roles 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 qualified regulatory professionals.
See All OPT Regulatory Affairs JobsOverview
Showing 5 of 100+ Regulatory Affairs jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 100+ Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs roles.
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 100+ OPT Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Regulatory Affairs
Target regulated industries first
Pharma, biotech, and medical device companies have dedicated regulatory departments and established visa sponsorship pipelines. These employers understand OPT timelines and are far more likely to support H-1B petitions than companies outside regulated industries.
Confirm your degree qualifies for STEM OPT
Regulatory Affairs roles typically require a STEM-classified degree such as biology, chemistry, pharmaceutical sciences, or biomedical engineering. Confirm your CIP code with your DSO before applying, since STEM OPT extension eligibility determines whether you get 12 or 36 months of work authorization.
Highlight relevant regulatory experience upfront
Employers weigh FDA submission experience, quality systems knowledge, and familiarity with regulations like 21 CFR heavily. Feature these in your resume summary and cover letter so hiring managers immediately understand your technical fit before evaluating your visa status.
Ask about sponsorship during the recruiter screen
Raise your OPT status during the first recruiter call, not after an offer. Ask directly whether the company has sponsored H-1B visas for Regulatory Affairs roles before. This saves time and signals that you're organized and transparent about your work authorization situation.
Pursue RAC or RAC-P certification proactively
The Regulatory Affairs Certification credential signals professional commitment and reduces employer hesitation around sponsorship. OPT students who hold or are actively pursuing RAC certification stand out in competitive candidate pools, especially for entry-level and associate-level regulatory positions.
Track your OPT end date and plan around H-1B timelines
H-1B petitions must be filed by April 1 for an October 1 start date. If your OPT expires before October, your STEM extension and employer's cap-exempt status matter. Map your authorization window before accepting offers to avoid gaps in employment eligibility.
Regulatory Affairs OPT: Frequently Asked Questions
Can I work in Regulatory Affairs on OPT?
Yes. Regulatory Affairs roles are eligible for OPT as long as the position is directly related to your degree field. Most qualifying degrees, including pharmacy, biology, chemistry, and biomedical engineering, are STEM-classified, which means you may be eligible for the 24-month STEM OPT extension on top of your initial 12-month authorization period.
Do Regulatory Affairs employers commonly sponsor H-1B visas?
Yes, particularly in pharma, biotech, and medical device companies. Regulatory Affairs is a specialized technical function, and employers in these industries have well-established H-1B sponsorship processes. Smaller companies and contract research organizations may sponsor less frequently, so it's worth confirming sponsorship history before investing time in the interview process. Migrate Mate filters job listings by sponsorship willingness to help you find the right fit.
What degrees qualify for STEM OPT extension in Regulatory Affairs?
Degrees in pharmaceutical sciences, biology, chemistry, biochemistry, biomedical engineering, and related STEM fields typically qualify. Your degree's CIP code determines eligibility, not the job title itself. Confirm your CIP code with your Designated School Official before applying for the extension. A qualifying STEM degree gives you up to 36 total months of OPT work authorization, which significantly expands your H-1B sponsorship window.
How should I explain my OPT status to a Regulatory Affairs employer?
Be direct and factual during the recruiter screen. Explain that you're authorized to work on OPT, specify your authorization end date, and note whether you qualify for the STEM extension. Mention that you'll need H-1B sponsorship before OPT expires. Regulatory Affairs employers in pharma and biotech are accustomed to this conversation and generally respond well to candidates who are organized and proactive about it.
What types of Regulatory Affairs roles are most accessible for OPT students?
Entry-level and associate regulatory affairs specialist roles are the most accessible. Positions focused on document management, submissions coordination, regulatory intelligence, and quality system support often welcome candidates with relevant internship experience and STEM degrees. Senior roles typically require several years of direct FDA interaction experience. Browse current Regulatory Affairs openings on Migrate Mate to find roles that specifically welcome OPT candidates.