E-3 Visa Regulatory Affairs Manager Jobs
Regulatory Affairs Manager roles qualify as E-3 visa specialty occupations, making them a strong fit for Australian professionals seeking U.S. sponsorship. The E-3 has no lottery and renews in two-year increments, so your career isn't tied to a single registration window the way H-1B visa holders' careers are.
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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 Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Regulatory Affairs Manager Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Regulatory Affairs Manager
Translate your TGA credentials for U.S. employers
Experience with the Therapeutic Goods Administration maps directly to FDA regulatory frameworks, but U.S. hiring managers may not make that connection automatically. Frame your TGA submissions and compliance work in terms of 21 CFR Part 11 and IND or NDA filing processes.
Target employers with active FDA dockets
Search the FDA's public drug or device approval databases to identify companies with recent 510(k), PMA, or NDA activity. These employers have active regulatory pipelines and a demonstrated need for the specialised oversight that a Regulatory Affairs Manager provides.
Clarify E-3 eligibility before the offer stage
Regulatory Affairs Manager roles routinely satisfy the E-3 specialty occupation requirement because the position normally demands a bachelor's degree in a relevant science, engineering, or regulatory discipline. Confirm this with your prospective employer before formal negotiations begin.
Request LCA filing the week your offer is signed
The DOL must certify your Labor Condition Application before you can apply for your E-3 visa. Delays here push back your consulate appointment, so ask your employer to submit the LCA through DOL's FLAG system immediately after your offer letter is executed.
Use Migrate Mate's E-3 filing service for the full process
Regulatory Affairs roles often involve complex job descriptions that need precise framing in the LCA and visa application. Migrate Mate's E-3 filing service manages your LCA submission, visa paperwork, and consulate preparation end-to-end so nothing stalls your start date.
Prepare for specialty occupation questions at the consulate
Consular officers occasionally probe whether a Regulatory Affairs Manager role genuinely requires a degree rather than general business experience. Bring your offer letter, an organisational chart showing the technical scope of the role, and copies of any relevant regulatory certifications.
E-3 Visa Regulatory Affairs Manager: Frequently Asked Questions
How do I find Regulatory Affairs Manager jobs that offer E-3 visa sponsorship?
Migrate Mate lets you filter job listings specifically by E-3 visa sponsorship, so you're not sorting through roles that won't support the visa. Regulatory Affairs Manager positions are listed by industry sector, which helps you target pharmaceutical, medical device, or biotech employers whose compliance needs align with your background.
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 Manager role qualify as an E-3 specialty occupation?
Yes. The E-3 specialty occupation requirement is satisfied when the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs Manager roles typically demand a degree in life sciences, pharmacy, engineering, or a related discipline, along with specialist knowledge of FDA or international regulatory frameworks, which meets that standard.
How does the E-3 visa compare to the H-1B for Regulatory Affairs Managers?
The E-3 has a 10,500 annual allocation that has never been exhausted, so there's no lottery. H-1B registrations are capped at 85,000 and subject to a randomised selection process that rejected roughly two-thirds of registrations in recent fiscal years. For an Australian Regulatory Affairs Manager, the E-3 provides a direct, predictable path without the lottery risk that makes H-1B sponsorship unreliable.
Can I switch employers or move to a contract role on an E-3 as a Regulatory Affairs Manager?
You can change employers, but each new position requires a fresh LCA certified by the DOL and a new E-3 visa application before you start work. Contract or consulting arrangements are more complicated because the E-3 requires an employer-employee relationship with a U.S. entity; purely independent contractor structures generally don't qualify.