J-1 Visa Senior Regulatory Affairs Specialist Jobs
Senior Regulatory Affairs Specialist roles in the United States are typically available to qualified professionals through the J-1 visa Specialist or Trainee program category, depending on your experience level. Finding a host employer willing to work with a designated J-1 sponsorship organization is the key step before any DS-2019 can be issued.
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If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The Department of Physiology & Biophysics has an exciting opportunity for a full-time Senior Research Associate 3 to work on-site in Miami.
CORE JOB SUMMARY
The Sr. Research Associate 3, SOM conducts highly specialized and complex research in support of the division’s research goals and objectives and assumes responsibility for the successful operations of the laboratory. The incumbent also supervises the activities of all laboratory staff and users and serves as subject matter expert and mentor to less experienced staff.
CORE JOB FUNCTIONS
- Contributes to basic and applied research activities by collecting and analyzing data.
- Understands and interprets research protocols and procedures.
- Maintains an overview of relevant research findings.
- Ensures all research is undertaken according to good research practice.
- Designs, evaluates, and implements methods and protocols for assigned research projects.
- Recommends purchase of new equipment for research projects.
- Writes scientific articles and manuscripts for publication and presentation.
- Oversees and ensures the safe handling of radioactive and hazardous materials.
- Prepares analytical reports relative to research data.
- Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
- Master's degree in relevant field required
- Minimum 3 years of relevant experience required
Knowledge, Skills and Abilities:
- Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
- Teamwork: Ability to work collaboratively with others and contribute to a team environment.
- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
DEPARTMENT ADDENDUM
Department Specific Functions
- Lead projects on G protein signaling, dopaminergic neuromodulation, and related pathways in striatal function
- Perform and innovate in biochemical assays, cellular signaling studies, genetic manipulations, and imaging experiments
- Collaborate on multidisciplinary studies
- Maintain meticulous records, laboratory notebooks, and analyze experimental data
- Contribute to a supportive, team-oriented lab culture.
Knowledge, Skills and Attitudes:
- Proven expertise in GPCR signaling, cellular biology, and neuronal models is required, along with a strong publication record and the ability to work independently yet collaboratively.
- Ideal candidates will also bring:
- Expertise in sterile tissue culture techniques
- Proficiency in molecular biology techniques, including AAV purification and cloning
- Experience with protein biochemistry approaches, including protein isolation and Western blot analysis
- Experience with confocal microscopy, immunocytochemistry, and immunohistochemistry
- Experience with mouse handling, dissections, and vibrating microtome tissue sectioning
- Ability to contribute toward general lab management and organization
- Proficiency with BRET and 2-photon imaging approaches (highly desirable)
- Excellent communication, organizational, and team skills
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status: Full time
Employee Type: Staff
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The Department of Physiology & Biophysics has an exciting opportunity for a full-time Senior Research Associate 3 to work on-site in Miami.
CORE JOB SUMMARY
The Sr. Research Associate 3, SOM conducts highly specialized and complex research in support of the division’s research goals and objectives and assumes responsibility for the successful operations of the laboratory. The incumbent also supervises the activities of all laboratory staff and users and serves as subject matter expert and mentor to less experienced staff.
CORE JOB FUNCTIONS
- Contributes to basic and applied research activities by collecting and analyzing data.
- Understands and interprets research protocols and procedures.
- Maintains an overview of relevant research findings.
- Ensures all research is undertaken according to good research practice.
- Designs, evaluates, and implements methods and protocols for assigned research projects.
- Recommends purchase of new equipment for research projects.
- Writes scientific articles and manuscripts for publication and presentation.
- Oversees and ensures the safe handling of radioactive and hazardous materials.
- Prepares analytical reports relative to research data.
- Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
- Master's degree in relevant field required
- Minimum 3 years of relevant experience required
Knowledge, Skills and Abilities:
- Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
- Teamwork: Ability to work collaboratively with others and contribute to a team environment.
- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
DEPARTMENT ADDENDUM
Department Specific Functions
- Lead projects on G protein signaling, dopaminergic neuromodulation, and related pathways in striatal function
- Perform and innovate in biochemical assays, cellular signaling studies, genetic manipulations, and imaging experiments
- Collaborate on multidisciplinary studies
- Maintain meticulous records, laboratory notebooks, and analyze experimental data
- Contribute to a supportive, team-oriented lab culture.
Knowledge, Skills and Attitudes:
- Proven expertise in GPCR signaling, cellular biology, and neuronal models is required, along with a strong publication record and the ability to work independently yet collaboratively.
- Ideal candidates will also bring:
- Expertise in sterile tissue culture techniques
- Proficiency in molecular biology techniques, including AAV purification and cloning
- Experience with protein biochemistry approaches, including protein isolation and Western blot analysis
- Experience with confocal microscopy, immunocytochemistry, and immunohistochemistry
- Experience with mouse handling, dissections, and vibrating microtome tissue sectioning
- Ability to contribute toward general lab management and organization
- Proficiency with BRET and 2-photon imaging approaches (highly desirable)
- Excellent communication, organizational, and team skills
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status: Full time
Employee Type: Staff
See all J-1 Visa Senior Regulatory Affairs Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new J-1 Visa Senior Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding J-1 Visa Sponsorship as a Senior Regulatory Affairs Specialist
Align your credentials to specialty occupation standards
Regulatory affairs work sits at the intersection of science and compliance. Before outreach, verify your degree field maps to the role using O*NET occupation data for Regulatory Affairs Specialists, since a misaligned credential is the fastest way to lose a host employer's interest.
Target host employers with regulatory infrastructure
Pharmaceutical, biotech, and medical device companies with in-house regulatory departments are far more likely to host J-1 Specialist or Trainee participants than generalist firms. Search for roles at companies with active FDA submission teams or global regulatory functions using Migrate Mate to filter for J-1-aligned positions.
Distinguish Trainee from Specialist category early
If you have fewer than five years of post-degree regulatory experience, the J-1 Trainee category applies. The Specialist category requires substantially more expertise. Getting this wrong delays your DS-2019, so confirm the correct category with your designated sponsor before your host employer drafts any training plan.
Build a training plan tied to regulatory milestones
Designated sponsors like Cultural Vistas or AIPT require a detailed training plan, not a job description. Map specific learning objectives to FDA, ICH, or EMA regulatory frameworks your host employer operates under, so the plan demonstrates structured knowledge transfer rather than routine employment.
Check whether your home country triggers the two-year rule
Regulatory affairs professionals from countries on the Exchange Visitor Skills List may face a two-year home residency requirement after their J-1 program ends. This affects your ability to change to H-1B visa or get a green card. Confirm your country's status with your designated sponsor before accepting any host offer.
Confirm your host employer's willingness to coordinate with a sponsor
Many U.S. employers conflate J-1 with direct employer-sponsored visas. During the offer stage, clarify that a designated sponsor organization issues the DS-2019 and monitors your program. Employers who understand this split structure close the process faster and with fewer compliance delays.
Senior Regulatory Affairs Specialist J-1 Visa: Frequently Asked Questions
Which J-1 program category applies to Senior Regulatory Affairs Specialist roles?
Most experienced regulatory affairs professionals qualify under the J-1 Specialist category, which is designed for individuals with specialized knowledge not widely available in the United States. If you have fewer than five years of relevant post-degree experience, the Trainee category may apply instead. Your designated sponsor organization makes the final determination based on your credentials, proposed training objectives, and host employer's program design.
Who actually sponsors the J-1 visa for a regulatory affairs role, and what does the host employer do?
The J-1 visa sponsor is a U.S. Department of State-designated organization, such as Cultural Vistas or AIPT, that issues your DS-2019 form and monitors program compliance. The hiring company is your host employer, not your visa sponsor. The host provides the work environment and training structure, but the designated sponsor holds legal responsibility for your exchange visitor program and must approve your training plan before you begin.
How do I find U.S. employers willing to host a J-1 regulatory affairs professional?
Regulatory affairs roles with J-1 hosting potential are concentrated in pharmaceutical, biotech, and medical device companies with established regulatory teams. Many of these employers don't advertise J-1 compatibility directly, so using Migrate Mate to search for roles aligned with J-1 sponsorship requirements saves significant time over filtering general job boards manually.
Does the two-year home residency requirement affect regulatory affairs J-1 participants?
It depends on your country of citizenship and whether your home government funded your exchange program or whether your occupation appears on the Exchange Visitor Skills List maintained by the State Department. Regulatory affairs is a technically specialized field, and some nationalities trigger the requirement automatically. If the two-year rule applies, you cannot change to H-1B or apply for a green card without first obtaining a waiver or completing the home residency period.
What should the training plan include for a J-1 Specialist in regulatory affairs?
The training plan must detail specific regulatory competencies you'll develop, not just job duties. For regulatory affairs, that means naming the specific frameworks involved, such as FDA 21 CFR submissions, ICH guidelines, or post-market surveillance protocols, and the learning milestones at each phase. Designated sponsors require this level of specificity to approve the program, and a vague plan tied to general job functions is the most common reason for delays in DS-2019 issuance.