H-1B Visa Regulatory Affairs Associate Jobs
Regulatory Affairs Associates help pharmaceutical, biotech, and medical device companies secure product approvals from the FDA and international agencies. The role qualifies as a specialty occupation under H-1B rules, requiring at least a bachelor's degree in a life sciences, pharmacy, or regulatory field. Many employers in this space have consistent H-1B filing histories.
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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 117+ 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 H-1B Visa Sponsorship as a Regulatory Affairs Associate
Align your degree to regulatory science
USCIS evaluates whether your degree directly relates to regulatory affairs. A degree in pharmaceutical sciences, chemistry, biology, or a related field strengthens your specialty occupation argument far more than a general science or business credential.
Search LCA filings by SOC code
Regulatory Affairs Associates fall under SOC 13-1041. Use the OFLC Wage Search to filter Labor Condition Applications by that code and identify employers actively certifying wages for this role before you apply.
Target FDA-regulated industries specifically
Pharmaceutical, biologics, and Class II or III medical device companies file H-1B petitions for this role far more consistently than consumer goods or general manufacturing firms. Narrowing your search to these subsectors improves your odds of finding sponsors on Migrate Mate.
Document your product submission experience
When negotiating the offer, provide your employer with a clear summary of your regulatory submissions, such as INDs, NDAs, 510(k)s, or CE marks. This documentation directly supports the employer's specialty occupation argument in the I-129 petition.
Clarify whether the employer uses PERM later
Some regulatory affairs roles are designated as hard-to-fill and qualify for Schedule A, bypassing the PERM labor certification process if you pursue a green card. Ask the hiring team whether they've filed Schedule A petitions for this role before.
Verify employer E-Verify enrollment early
If you're on OPT STEM extension, your employer must be enrolled in E-Verify. Confirm enrollment before accepting an offer. Migrate Mate shows employer verification status alongside LCA filing history so you can check both in one place.
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Find Regulatory Affairs Associate JobsRegulatory Affairs Associate H-1B Visa: Frequently Asked Questions
Does a Regulatory Affairs Associate role qualify as a specialty occupation for H-1B purposes?
Yes, regulatory affairs roles typically qualify because they require specialized knowledge in life sciences, pharmacy, chemistry, or a related field, and employers generally require at least a bachelor's degree in those disciplines. USCIS reviews the job description and the employer's actual hiring practices, so the offer letter and job posting should reflect a specific degree requirement rather than listing a general science background as acceptable.
Which industries sponsor H-1B visas most consistently for this role?
Pharmaceutical companies, biologics manufacturers, and medical device firms that operate under FDA oversight file Labor Condition Applications for this title far more regularly than other sectors. Contract research organizations and regulatory consulting firms also sponsor, though their filing patterns vary. You can filter by industry and occupation code using the OFLC Wage Search or browse employer-verified listings on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA approval or downsizes the regulatory team?
If your employer terminates your position, USCIS provides a 60-day grace period during which you can find a new sponsoring employer. Your new employer must file an H-1B transfer petition before that window closes. Regulatory affairs professionals moving between FDA-regulated companies often qualify for cap-exempt transfers if the new employer is a nonprofit or government research entity.
Does my foreign regulatory experience with EMA or Health Canada count toward H-1B specialty occupation?
Yes, USCIS considers international regulatory experience when evaluating whether a position qualifies as a specialty occupation and whether you meet the qualifications. Experience with EMA submissions, CE marking, or Health Canada approvals demonstrates specialized knowledge that supports the petition. Document that experience in your resume and provide supporting letters from prior employers or clients when your employer files the I-129.
How do I find employers who actively sponsor H-1B visas for Regulatory Affairs Associate roles?
Migrate Mate surfaces employers with verified H-1B LCA filing history filtered to this specific occupation. You can identify pharmaceutical, biotech, and medical device companies that have filed Labor Condition Applications for regulatory roles, confirm their E-Verify enrollment status if you're on OPT, and apply directly through listings that already confirm sponsorship intent.
See which Regulatory Affairs Associate employers are hiring and sponsoring visas right now.
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