E-3 Visa Regulatory Affairs Jobs
Regulatory Affairs professionals bring the credential-heavy, degree-specific background that E-3 visa sponsorship is built for. Your science or health sciences degree maps directly to specialty occupation requirements, and the E-3's no-lottery structure means you can target U.S. roles without waiting on an annual cap draw.
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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 a 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 North Chicago, IL; Florham Park, NJ or Irvine, CA 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: Four 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 short-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 a 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 North Chicago, IL; Florham Park, NJ or Irvine, CA 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: Four 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 short-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 52+ E-3 Visa Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship in Regulatory Affairs
Translate your TGA experience for U.S. employers
Reframe your Therapeutic Goods Administration background in terms of FDA equivalents, 21 CFR Part 11, 510(k) submissions, NDA or BLA processes. U.S. hiring managers read TGA experience as credible but need the translation to move your application forward.
Target FDA-regulated industries with active LCA filings
Pharma, medical devices, and biologics companies file Labor Condition Applications regularly for Regulatory Affairs roles. Search DOL's OFLC disclosure data by job title to identify employers with recent E-3 visa LCA history before you apply.
Confirm your degree field supports specialty occupation status
Regulatory Affairs requires a direct nexus between your degree and the role. A degree in pharmacy, biochemistry, biomedical science, or a related field strengthens your E-3 application. A general business degree, even with years of RA experience, can trigger an USCIS request for evidence.
Get your offer letter to specify regulatory duties precisely
Vague offer letters that list Regulatory Affairs broadly are a common E-3 stumbling block. Ask your employer to specify the regulatory frameworks you'll work under, FDA submissions, compliance audits, labeling reviews, so the LCA and visa application are defensible.
Use Migrate Mate's E-3 filing service for the LCA and consulate prep
Regulatory Affairs E-3 applications often involve detailed specialty occupation documentation. Migrate Mate's E-3 filing service handles your LCA filing with DOL, prepares your visa paperwork, and gets you ready for your consulate appointment without needing a separate immigration lawyer.
Understand the E-3 timeline before you accept an offer
The DOL certifies LCAs within seven business days, but Australian consulate appointment availability varies by location and season. Factor in two to six weeks from LCA certification to visa interview when negotiating your start date with a U.S. employer.
E-3 Visa Regulatory Affairs: Frequently Asked Questions
How do I find Regulatory Affairs jobs with E-3 visa sponsorship?
Migrate Mate is the most direct way to search, it filters roles by E-3 sponsorship eligibility so you're only seeing employers already set up to hire Australian professionals. Regulatory Affairs roles in pharma, medical devices, and biologics are the most active categories for E-3 filings in the life sciences sector.
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 Regulatory Affairs qualify as a specialty occupation for the E-3?
Yes, provided your degree is in a directly related field such as pharmacy, biochemistry, regulatory science, or biomedical engineering. USCIS assesses specialty occupation on a role-by-role basis, so the offer letter needs to tie specific regulatory duties, FDA submissions, compliance documentation, labeling review, to your degree field explicitly.
How does the E-3 compare to H-1B for Regulatory Affairs professionals?
The E-3 is significantly more practical for Australians in this field. There's no lottery, no annual cap pressure, and you can apply at any time of year once you have a job offer and a certified LCA. H-1B visa selection is randomized and capped at 85,000 annually, meaning a qualified Regulatory Affairs professional can wait years for a slot. The E-3 gets you to a consulate appointment within weeks of your offer.
Can I switch employers on an E-3 while working in Regulatory Affairs?
Yes, but the E-3 is employer-tied, so your new employer must file a fresh LCA with DOL and support a new visa application before you start. There's no portability provision like AC21 under the H-1B. If you're changing roles within the same company, a material change in duties may also require an amended filing.