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 AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.
Responsibilities:
- Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
- Acts as RA Submissions interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
- Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
- Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks.
- May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
- Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
- Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in moderately complex submissions. Facilitates team reviews.
- Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
- Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
- Contributes to the creation, and implementation of internal process and standards documents relating to publishing and publishing deliverables.
- Position accountability/scope:
- Some supervision required
- Receives project assignments from manager but has responsibility for managing own projects with some oversight
- Reviews project progress with manager on a regular basis with direction provided by manager
- Trains, and mentors less experienced staff.
- This position will work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie Florham Park, NJ or North Chicago, IL headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
- Required Education: Bachelor’s degree.
- Note: Years of experience may also compensate for lower education.
- Preferred Education: PMP and RAC certificates a plus.
- Required Experience: 4 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
- Preferred Experience:
- Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area.
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
- Proven leadership skills and presence.
- NOTE: Higher education may compensate for years of experience.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.
Responsibilities:
- Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
- Acts as RA Submissions interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
- Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
- Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks.
- May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
- Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
- Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in moderately complex submissions. Facilitates team reviews.
- Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
- Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
- Contributes to the creation, and implementation of internal process and standards documents relating to publishing and publishing deliverables.
- Position accountability/scope:
- Some supervision required
- Receives project assignments from manager but has responsibility for managing own projects with some oversight
- Reviews project progress with manager on a regular basis with direction provided by manager
- Trains, and mentors less experienced staff.
- This position will work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie Florham Park, NJ or North Chicago, IL headquarters.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
- Required Education: Bachelor’s degree.
- Note: Years of experience may also compensate for lower education.
- Preferred Education: PMP and RAC certificates a plus.
- Required Experience: 4 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
- Preferred Experience:
- Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area.
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
- Proven leadership skills and presence.
- NOTE: Higher education may compensate for years of experience.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
See all 35+ 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.