Regulatory Affairs Associate Jobs in USA with Visa Sponsorship
Regulatory Affairs Associates working in pharmaceuticals, medical devices, and biotech regularly receive H-1B visa and O-1 visa sponsorship. The role qualifies as a specialty occupation requiring a bachelor's degree or higher in a scientific or regulatory field, making employer sponsorship straightforward for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsCompany Description
About Collabera:
Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.
With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.
- Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)
- Collabera listed in GS 100 - recognized for excellence and maturity
- Collabera named among the Top 500 Diversity Owned Businesses
- Collabera listed in GS 100 & ranked among top 10 service providers
- Collabera was ranked:
- 32 in the Top 100 Large Businesses in the U.S
- 18 in Top 500 Diversity Owned Businesses in the U.S
- 3 in the Top 100 Diversity Owned Businesses in New Jersey
- 3 in the Top 100 Privately-held Businesses in New Jersey
- 66th on FinTech 100
- 35th among top private companies in New Jersey
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Job Description
Core job responsibilities for this position include:
-
Ensure Area & Affiliate users have appropriate access to RSC and LEx for their daily job responsibilities.
a. Create and submit user access forms.
b. Manage QlikView license allocation to ensure users have access as necessary while appropriately managing RA funding resources.
c. Facilitate a review of User Access Lists on an annual basis to clean up user tables. -
Ensure that Area & Affiliate users are assigned the appropriate roles in RSC and LEx.
a. Add/Modify Affiliate Regulatory Managers in RSC as personnel change and as new products are launched in new markets.
b. Add/Modify Affiliate Regulatory Contacts in Launch Excellence as personnel change and as new products are launched in new markets.
c. Update RSC Rosters for notifications based on requests from Area & Affiliate users.
d. Request and post RSC Roster lists on a monthly basis to ensure most up-to-date information is available to users. -
Monitor Area & Affiliate Systems Support mailbox (??) to provide Level 1 support to users regarding RSC and LEx.
-
Manage change requests submitted by users to help facilitate discussions on future releases of Launch Excellence.
-
Support cross-functional team meetings on Launch Excellence by documenting and posting meeting minutes and drafting presentation material as requested.
-
Map submission and approval information received via RSC to records in Launch Excellence for updates.
-
Create RSC records for distribution of CCDS Updates and other centrally managed product changes.
-
Generate monthly reports for management on Launch Excellence activity.
-
Review user issue logs and make recommendations for additional training sessions or materials to help support users.
-
Support other activities as necessary to ensure successful utilization of RSC and Launch Excellence for Area & Affiliate.
Qualifications
Bachelor’s degree in a life science, clinical research studies or information technology required. Degree in chemistry, biological science, or pharmacy preferred.
Minimum of 1-3 years previous regulatory affairs experience preferred. Experience with regulatory submissions in international markets, especially emerging markets preferred. 5 or more years experience in the pharmaceutical industry in one of the following areas (R&D, Manufacturing Operations, Quality Assurance, Regulatory Affairs and/or Clinical) required.
All your information will be kept confidential according to EEO guidelines.
Company Description
About Collabera:
Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.
With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.
- Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)
- Collabera listed in GS 100 - recognized for excellence and maturity
- Collabera named among the Top 500 Diversity Owned Businesses
- Collabera listed in GS 100 & ranked among top 10 service providers
- Collabera was ranked:
- 32 in the Top 100 Large Businesses in the U.S
- 18 in Top 500 Diversity Owned Businesses in the U.S
- 3 in the Top 100 Diversity Owned Businesses in New Jersey
- 3 in the Top 100 Privately-held Businesses in New Jersey
- 66th on FinTech 100
- 35th among top private companies in New Jersey
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.
Job Description
Core job responsibilities for this position include:
-
Ensure Area & Affiliate users have appropriate access to RSC and LEx for their daily job responsibilities.
a. Create and submit user access forms.
b. Manage QlikView license allocation to ensure users have access as necessary while appropriately managing RA funding resources.
c. Facilitate a review of User Access Lists on an annual basis to clean up user tables. -
Ensure that Area & Affiliate users are assigned the appropriate roles in RSC and LEx.
a. Add/Modify Affiliate Regulatory Managers in RSC as personnel change and as new products are launched in new markets.
b. Add/Modify Affiliate Regulatory Contacts in Launch Excellence as personnel change and as new products are launched in new markets.
c. Update RSC Rosters for notifications based on requests from Area & Affiliate users.
d. Request and post RSC Roster lists on a monthly basis to ensure most up-to-date information is available to users. -
Monitor Area & Affiliate Systems Support mailbox (??) to provide Level 1 support to users regarding RSC and LEx.
-
Manage change requests submitted by users to help facilitate discussions on future releases of Launch Excellence.
-
Support cross-functional team meetings on Launch Excellence by documenting and posting meeting minutes and drafting presentation material as requested.
-
Map submission and approval information received via RSC to records in Launch Excellence for updates.
-
Create RSC records for distribution of CCDS Updates and other centrally managed product changes.
-
Generate monthly reports for management on Launch Excellence activity.
-
Review user issue logs and make recommendations for additional training sessions or materials to help support users.
-
Support other activities as necessary to ensure successful utilization of RSC and Launch Excellence for Area & Affiliate.
Qualifications
Bachelor’s degree in a life science, clinical research studies or information technology required. Degree in chemistry, biological science, or pharmacy preferred.
Minimum of 1-3 years previous regulatory affairs experience preferred. Experience with regulatory submissions in international markets, especially emerging markets preferred. 5 or more years experience in the pharmaceutical industry in one of the following areas (R&D, Manufacturing Operations, Quality Assurance, Regulatory Affairs and/or Clinical) required.
All your information will be kept confidential according to EEO guidelines.
See all 144+ Regulatory Affairs Associate jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Associate roles.
Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Associate
Target FDA-regulated industries first
Pharmaceutical, biotech, and medical device companies have established immigration programs and sponsor Regulatory Affairs Associates at higher rates than other sectors. These employers file LCAs and H-1B petitions routinely, which means faster internal approval processes for sponsorship requests.
Document your degree's relevance to the role
USCIS requires a direct relationship between your degree field and the job duties. Degrees in life sciences, chemistry, pharmacology, or biomedical engineering map cleanly. If your degree is adjacent, gather course transcripts that demonstrate regulatory, scientific, or compliance coursework.
Highlight submission experience in your resume
Employers sponsoring H-1B petitions need to prove the role requires specialized knowledge. Listing specific submissions, such as 510(k)s, INDs, or CTAs, strengthens both your candidacy and the specialty occupation argument USCIS evaluates during petition review.
Apply to companies with existing RAA headcount
Companies that already employ Regulatory Affairs Associates on H-1B status have proven their HR and legal teams can handle the process. Joining an established regulatory department significantly reduces friction compared to being the first sponsored employee in that function.
Understand the H-1B lottery timing before accepting offers
If you need cap-subject H-1B sponsorship, registration opens in March for an October 1 start. Clarify your current status and timeline with each employer early in interviews so both parties understand what bridging arrangements, such as OPT extension, may be needed.
Consider contract and CRO roles as entry points
Contract Research Organizations and staffing agencies that place regulatory professionals often sponsor visas and can be faster to move than large pharma legal teams. A contract role with sponsorship builds U.S. regulatory experience that strengthens future full-time petitions.
Regulatory Affairs Associate jobs are hiring across the US. Find yours.
Find Regulatory Affairs Associate JobsFrequently Asked Questions
Does a Regulatory Affairs Associate role qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Associate positions consistently qualify as H-1B specialty occupations because they require at least a bachelor's degree in a specific scientific or regulatory field, life sciences, chemistry, biomedical engineering, or pharmacy are the most common. USCIS has approved thousands of H-1B petitions for this job title across pharmaceutical and medical device companies. The role's technical complexity and degree requirement make denial on specialty occupation grounds uncommon when the petition is properly documented.
Which visa types do Regulatory Affairs Associates most commonly receive sponsorship for?
H-1B is the most common visa for Regulatory Affairs Associates. Candidates with extraordinary achievement in regulatory science, such as published research or leadership on major submissions, sometimes qualify for O-1A. Australians with the right credentials should explore the E-3 visa, which skips the H-1B lottery entirely and is easier for employers to process. Use Migrate Mate to filter job listings by visa type and identify which sponsoring employers are actively hiring.
Do employers in pharma and biotech routinely sponsor Regulatory Affairs Associates?
Yes, sponsorship rates are high in this field. Large pharmaceutical companies, mid-size biotechs, and medical device manufacturers all hire internationally and have immigration counsel on retainer. DOL LCA disclosure data consistently shows companies like Johnson & Johnson, Pfizer, and Abbott filing for Regulatory Affairs roles. Smaller companies and startups sponsor less predictably, so it is worth confirming sponsorship willingness early in the interview process.
Can I qualify for Regulatory Affairs Associate sponsorship with a non-science degree?
It depends on the specific degree and how closely it relates to the regulatory function. A degree in public health, law, or even engineering can support a petition if your coursework or professional experience maps to regulatory compliance. USCIS evaluates whether the degree is in a directly related field. A credential evaluation and a strong job description tying your background to regulatory requirements will be necessary. An immigration attorney can assess your specific profile before you apply.
What documents does my employer need to sponsor my H-1B as a Regulatory Affairs Associate?
Your employer needs to file a Labor Condition Application with the Department of Labor, then submit Form I-129 to USCIS with supporting documentation. That includes a detailed job description outlining the regulatory duties and degree requirements, proof of your qualifications, and evidence the employer can pay the prevailing wage. For Regulatory Affairs roles, employers often include examples of the regulatory submissions the position manages to strengthen the specialty occupation argument.
What is the prevailing wage requirement for sponsored Regulatory Affairs Associate jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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