H-1B Visa Regulatory Affairs Jobs
Regulatory Affairs roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in life sciences, pharmacy, or a related technical field. Employers in pharma, biotech, and medical devices file LCAs with the DOL before sponsoring, and many actively recruit internationally trained RA professionals.
Find H-1B Visa Regulatory Affairs JobsOverview
Showing 5 of 287+ Regulatory Affairs jobs
See all 287+ 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 JobsUniversity Staff
Description
University of Colorado Anschutz Medical Campus
Department: Ophthalmology
Job Title: Regulatory Affairs Program Manager
Position #00849808 – Requisition #40277
Job Summary:
The Department of Ophthalmology has an immediate opening for a full-time Research Services Program Manager-Regulatory Affairs Program Manager. The position will independently maintain and manage all IRB and regulatory processes for department research studies. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals including SARC, Oncore, InfoEd and others; acting as primary regulatory contact person for department faculty and research staff, sponsors/Contract Research Organizations (CROs)/coordinating centers; maintaining research credentials, training documentation and licenses; The Regulatory Affairs Coordinator will work closely with the Director of Clinical Research, program managers, and clinical research coordinators.
Key Responsibilities:
- Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
- Coordinate regulatory documentation for industry-sponsored clinical trials and investigator-initiated studies for all clinical research in Ophthalmology.
- Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
- Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
- Track and maintain investigator qualifications, including CVs, medical licenses, training documentation, and financial disclosures.
- Assist with protocol and consent form development.
- Develop, implement, and maintain departmental SOPs, templates, guidance documents, and regulatory workflows.
- Assist investigators and study teams with regulatory start-up activities, including feasibility documentation and site qualification materials.
- Maintain investigator site files (ISF) and ensure all required documents are current and complete.
- Prepare regulatory documentation for monitoring visits, sponsor audits, and regulatory inspections.
- Assist with regulatory reporting of adverse events, unanticipated problems, and protocol deviations as required by IRB and sponsors.
- Work closely with investigators and study teams to ensure regulatory compliance for specialized ophthalmology research protocols.
- Develop and maintain regulatory tracking systems for submissions, approvals, and expiration dates, as well as staff training.
- Lead and mentor regulatory coordinators and other research staff.
- Collaborate with departmental leadership on strategic growth opportunities, process optimization, and operational enhancements.
Work Location:
Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.
Why Join Us:
The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.
The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields.
The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership, innovative research, and high ethical standards.
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 15/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
Qualifications
Minimum Qualifications:
- Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 4-6 years of professional experience related to regulatory affairs in research administration.
- A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
- Master’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution.
- Experience working with in ophthalmology and/or clinical research.
- IRB experience (COMIRB or central IRBs, such as WCG or Advarra).
- Experience drafting and editing study protocols and informed consent documents.
- Experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, RedCap and InfoED).
Competencies: Knowledge, Skills, and Abilities
- Ability to communicate effectively, both in writing and orally.
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills.
How to Apply:
For full consideration, please submit the following document(s):
- A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
- Curriculum vitae / Resume
- Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Questions should be directed to:
Ashley Woodhouse
ashley.woodhouse@cuanschutz.edu
Screening of Applications Begins:
Immediately and continues until June 23rd, 2026.
Anticipated Pay Range:
The starting salary range for this position has been established as $74,627 - $94,925.
The above salary range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator
Equal Employment Opportunity Statement:
CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.
Background Check Statement:
The University of Colorado Anschutz is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Application Materials Required:
Cover Letter, Resume/CV, List of References
Job Category:
Research Services
Primary Location:
Aurora
Department:
U0001 - Anschutz Med Campus or Denver - 20254 - SOM-OP GENERAL OPERATIONS
Schedule:
Full-time
Posting Date:
Jun 19, 2026
Unposting Date:
Jun 25, 2026, 12:59:00 AM
Posting Contact Name:
Ashley Woodhouse
Posting Contact Email:
ashley.woodhouse@cuanschutz
Position Number:
00849808
University Staff
Description
University of Colorado Anschutz Medical Campus
Department: Ophthalmology
Job Title: Regulatory Affairs Program Manager
Position #00849808 – Requisition #40277
Job Summary:
The Department of Ophthalmology has an immediate opening for a full-time Research Services Program Manager-Regulatory Affairs Program Manager. The position will independently maintain and manage all IRB and regulatory processes for department research studies. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals including SARC, Oncore, InfoEd and others; acting as primary regulatory contact person for department faculty and research staff, sponsors/Contract Research Organizations (CROs)/coordinating centers; maintaining research credentials, training documentation and licenses; The Regulatory Affairs Coordinator will work closely with the Director of Clinical Research, program managers, and clinical research coordinators.
Key Responsibilities:
- Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
- Coordinate regulatory documentation for industry-sponsored clinical trials and investigator-initiated studies for all clinical research in Ophthalmology.
- Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
- Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
- Track and maintain investigator qualifications, including CVs, medical licenses, training documentation, and financial disclosures.
- Assist with protocol and consent form development.
- Develop, implement, and maintain departmental SOPs, templates, guidance documents, and regulatory workflows.
- Assist investigators and study teams with regulatory start-up activities, including feasibility documentation and site qualification materials.
- Maintain investigator site files (ISF) and ensure all required documents are current and complete.
- Prepare regulatory documentation for monitoring visits, sponsor audits, and regulatory inspections.
- Assist with regulatory reporting of adverse events, unanticipated problems, and protocol deviations as required by IRB and sponsors.
- Work closely with investigators and study teams to ensure regulatory compliance for specialized ophthalmology research protocols.
- Develop and maintain regulatory tracking systems for submissions, approvals, and expiration dates, as well as staff training.
- Lead and mentor regulatory coordinators and other research staff.
- Collaborate with departmental leadership on strategic growth opportunities, process optimization, and operational enhancements.
Work Location:
Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.
Why Join Us:
The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.
The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields.
The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership, innovative research, and high ethical standards.
Why work for the University?
We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 15/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
There are many additional perks & programs with the CU Advantage.
Qualifications
Minimum Qualifications:
- Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 4-6 years of professional experience related to regulatory affairs in research administration.
- A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
Preferred Qualifications:
- Master’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution.
- Experience working with in ophthalmology and/or clinical research.
- IRB experience (COMIRB or central IRBs, such as WCG or Advarra).
- Experience drafting and editing study protocols and informed consent documents.
- Experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, RedCap and InfoED).
Competencies: Knowledge, Skills, and Abilities
- Ability to communicate effectively, both in writing and orally.
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
- Outstanding customer service skills.
How to Apply:
For full consideration, please submit the following document(s):
- A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
- Curriculum vitae / Resume
- Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Questions should be directed to:
Ashley Woodhouse
ashley.woodhouse@cuanschutz.edu
Screening of Applications Begins:
Immediately and continues until June 23rd, 2026.
Anticipated Pay Range:
The starting salary range for this position has been established as $74,627 - $94,925.
The above salary range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator
Equal Employment Opportunity Statement:
CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.
Background Check Statement:
The University of Colorado Anschutz is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
Application Materials Required:
Cover Letter, Resume/CV, List of References
Job Category:
Research Services
Primary Location:
Aurora
Department:
U0001 - Anschutz Med Campus or Denver - 20254 - SOM-OP GENERAL OPERATIONS
Schedule:
Full-time
Posting Date:
Jun 19, 2026
Unposting Date:
Jun 25, 2026, 12:59:00 AM
Posting Contact Name:
Ashley Woodhouse
Posting Contact Email:
ashley.woodhouse@cuanschutz
Position Number:
00849808
See all 287+ H-1B Visa Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs
Align your degree to FDA submission work
USCIS scrutinizes whether your degree field directly supports the specific RA duties in the job description. A chemistry or biology degree paired with regulatory coursework strengthens specialty occupation arguments far more than a general science background.
Search LCA filings before applying anywhere
Use Migrate Mate to filter employers by verified DOL LCA filing history in Regulatory Affairs. This surfaces companies that have already demonstrated H-1B sponsorship intent for this job code, cutting your search time significantly.
Target employers with dedicated RA departments
Standalone RA departments at mid-size pharma and Class II medical device companies sponsor more consistently than generalist consulting firms. O*NET classifies Regulatory Affairs Specialists under SOC 13-1041, which you can cross-reference against OFLC disclosure data.
Negotiate LCA filing into your offer timeline
The DOL must certify your LCA before USCIS receives the I-129 petition. Ask your employer to begin the LCA at least three weeks before your intended start date so certification doesn't delay your H-1B effective date.
Document foreign regulatory experience for RFEs
If you've worked with EMA, Health Canada, or TGA submissions, get official employer letters specifying submission types and your exact role. USCIS RFEs on RA petitions frequently challenge whether non-U.S. experience maps to the specialty occupation standard.
Verify your employer's E-Verify enrollment status
H-1B employers must be E-Verify participants to request cap-exempt processing through certain institutions or to rehire H-1B workers portably. Confirm enrollment before your final offer acceptance, not after signing.
H-1B Visa Regulatory Affairs: Frequently Asked Questions
Does a Regulatory Affairs job qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Specialist roles require theoretical and practical application of life sciences, pharmacy, chemistry, or engineering knowledge at the bachelor's degree level or higher. USCIS has approved H-1B petitions for RA roles across pharma, biotech, and medical device sectors. The employer's job description must specify degree requirements that are directly related to RA duties, not just broadly preferred.
Which industries sponsor H-1B visas most often for Regulatory Affairs professionals?
Pharmaceutical manufacturers, biologics companies, Class II and Class III medical device firms, and CROs file the largest volume of H-1B LCAs for Regulatory Affairs roles. Biotech startups preparing for IND or NDA submissions also sponsor frequently because RA expertise is scarce domestically. You can browse employers with active H-1B filing history for this role category on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA contract or restructures the RA team?
You have a 60-day grace period after involuntary termination to find new H-1B sponsorship, change to another status, or depart the U.S. Under AC21 portability rules, if your I-140 has been approved and your I-485 has been pending for 180 days or more, you can port to a same or similar RA role with a new employer without losing your priority date.
How does the prevailing wage requirement affect H-1B sponsorship for Regulatory Affairs roles?
Your employer must pay at least the DOL prevailing wage for the RA job title, level, and work location. Prevailing wages are set at four wage levels based on experience and complexity. You can look up the applicable wage yourself using the OFLC Wage Search before negotiations. Employers who underpay relative to the certified LCA wage risk DOL audit and back-pay liability.
Can I transfer my H-1B to a new Regulatory Affairs employer mid-sponsorship?
Yes. H-1B portability lets you start working for a new H-1B employer as soon as the new I-129 petition is filed, not after approval. The new role must be in the same or a substantially similar RA occupational classification. Your new employer files a new LCA and I-129; you don't restart the lottery. This makes lateral moves within RA feasible without status gaps.