E-3 Visa Regulatory Affairs Associate Jobs
Regulatory Affairs Associates working in pharmaceuticals, medical devices, or biotechnology qualify for E-3 visa sponsorship as a specialty occupation requiring a relevant bachelor's degree. The E-3 has no lottery and no annual cap, so Australian professionals can pursue U.S. roles year-round without waiting for an H-1B visa selection cycle.
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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 E-3 Visa Regulatory Affairs Associate Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Regulatory Affairs Associate Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Regulatory Affairs Associate
Align your credentials to U.S. regulatory frameworks
Australian TGA experience translates directly to FDA regulatory work, but your resume should name specific frameworks, 21 CFR Part 11, IND submissions, or 510(k) pathways, so hiring managers and USCIS reviewers both see the specialty occupation connection clearly.
Target employers with active LCA filing history
Pharma manufacturers, CROs, and medical device companies that file Labor Condition Applications regularly already understand E-3 visa sponsorship obligations. Search DOL's OFLC disclosure data to confirm a company has sponsored foreign nationals in regulatory roles before approaching them.
Clarify sponsorship scope before accepting an offer
Some employers treat E-3 sponsorship as covering only the LCA, leaving you to handle the DS-160 and consulate prep alone. Confirm upfront whether the company will manage the full filing or expects you to coordinate parts of the process independently.
Use Migrate Mate's E-3 filing service for end-to-end support
Once you have a signed offer, use Migrate Mate's E-3 filing service to handle your LCA and visa paperwork. This is especially useful when your employer has no prior E-3 experience and needs guidance on DOL certification requirements and prevailing wage obligations.
Request a certified LCA before your consulate appointment
The LCA must be DOL-certified before you can attend your visa interview. DOL targets seven business days for certification, but delays happen. Build at least two weeks of buffer between your employer's submission date and your scheduled consulate appointment.
Prepare a specialty occupation evidence packet for your interview
Consular officers assess whether your role genuinely requires a degree in a specific field. Bring your official academic transcripts, a detailed job description naming regulatory responsibilities, and any TGA or FDA certifications that substantiate the technical nature of your work.
E-3 Visa Regulatory Affairs Associate: Frequently Asked Questions
How do I find Regulatory Affairs Associate jobs that offer E-3 visa sponsorship?
Migrate Mate is built specifically for this search. It filters roles by E-3 sponsorship readiness so you're not applying blind to companies that have never sponsored an Australian before. Regulatory Affairs positions in pharma, biotech, and medical devices appear regularly, particularly at companies with FDA submission pipelines that need international regulatory expertise.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Regulatory Affairs Associate role qualify as a specialty occupation for the E-3?
Yes. Regulatory Affairs Associate positions typically require a bachelor's degree in life sciences, pharmacy, biomedical engineering, or a related field, which satisfies the E-3 specialty occupation requirement. USCIS and consular officers look for a direct connection between your degree field and the regulatory responsibilities in the job description, so ensure your offer letter is specific about duties.
How does the E-3 compare to the H-1B for Regulatory Affairs Associate roles?
The E-3 is available exclusively to Australian citizens and has no lottery. H-1B selection is randomized and capped at 85,000 per fiscal year, meaning qualified candidates are regularly not selected. For regulatory professionals, the E-3 is the more reliable path because you can apply at any time of year as soon as you have a qualifying job offer and a certified LCA.
Can I switch employers while on an E-3 as a Regulatory Affairs Associate?
Yes, but the process restarts with each new employer. Your new employer must file a fresh LCA with DOL, and you'll need to attend a new consulate interview to receive an updated E-3 visa stamp. There's no portability provision as with some other visa categories, so factor in a two-to-four week transition window when negotiating your start date.