E-3 Visa Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialist roles qualify as E-3 specialty occupations, requiring a bachelor's degree in a life sciences, pharmacy, or related field. Australian professionals can secure E-3 visa sponsorship without competing in the H-1B lottery, with no annual cap limiting available slots and indefinite two-year renewals tied to your employment.
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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 Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Regulatory Affairs Specialist
Align your Australian credentials to U.S. standards
A three-year Australian bachelor's in pharmacy, chemistry, or biomedical science is generally accepted as equivalent to a U.S. four-year degree for E-3 visa purposes. Have a credential evaluation ready before you apply, as some employers request it during screening.
Target FDA-regulated industries with active hiring
Pharmaceutical manufacturers, medical device companies, and biotech firms routinely need regulatory affairs staff to manage FDA submissions. These employers understand specialty occupation requirements, so your E-3 sponsorship conversation starts from a much better position than with general employers.
Search verified E-3 sponsorship roles on Migrate Mate
Use Migrate Mate to find Regulatory Affairs Specialist positions where employers already understand E-3 sponsorship. Filtering by roles with verified sponsorship history saves you from pursuing companies unfamiliar with the visa process.
Clarify LCA obligations with your prospective employer
Before accepting an offer, confirm your employer will file the Labor Condition Application with the DOL. The LCA certifies your offered wage meets prevailing rates for your location and role level, and it must be certified before your consulate appointment.
Use Migrate Mate's E-3 filing service for your paperwork
Once you have an offer, use Migrate Mate's E-3 filing service to handle your LCA and visa paperwork end-to-end. Regulatory affairs roles often involve detailed specialty occupation documentation, and getting the job classification right the first time avoids consulate delays.
Prepare for consulate questions about your regulatory scope
Consular officers assess whether your role genuinely requires a degree-level specialist. Bring documentation linking your specific duties, such as IND or 510(k) submission responsibilities, to your academic qualifications so the specialty occupation connection is unmistakable.
E-3 Visa Regulatory Affairs Specialist: Frequently Asked Questions
How do I find Regulatory Affairs Specialist jobs with E-3 visa sponsorship?
Migrate Mate is the most direct way to search for Regulatory Affairs Specialist roles where employers are already open to E-3 sponsorship. Standard job boards rarely flag visa sponsorship type, so you can spend weeks reaching out to companies that only sponsor H-1B. Migrate Mate filters by E-3-compatible employers, saving you that time.
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 Specialist role qualify as an E-3 specialty occupation?
Yes. Regulatory affairs work requires specialized knowledge of FDA regulations, submission processes, and compliance frameworks that directly map to a bachelor's degree or higher in pharmacy, chemistry, biomedical science, or a related field. USCIS and consular officers assess each role individually, so your offer letter should clearly describe duties tied to that educational background rather than generalized project management tasks.
How does the E-3 compare to the H-1B for Regulatory Affairs Specialists?
The E-3 has a 10,500 annual allocation that has never been fully used, so there is no lottery and no random selection. H-1B has an 85,000 cap with registration lottery odds well below 50 percent in recent years. For an Australian regulatory affairs professional with a qualifying offer, the E-3 is a direct path to a consulate appointment, typically within weeks of LCA certification.
Can I change employers or move to a different regulatory role while on E-3?
Yes, but each employer change requires a new LCA and a new visa stamp if you travel outside the U.S. Your new employer files the LCA with the DOL certifying the wage and working conditions for the new role. If your duties shift significantly, such as moving from device regulatory affairs to pharmaceutical submissions, the new employer should ensure the specialty occupation documentation reflects the updated scope.