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
Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs.
- This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
- Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support. Provides direction and technical insight when necessary to ensure real-time guidance.
- Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel. May also serve as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
- Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
- Operates independently, with recognition of when to consult management. Makes decisions and plans for operations workflow, assignments within area of responsibility with minimal direction.
- Assists in the development, training, and mentoring of junior staff members.
- Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review. Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
- Demonstrates solid understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory.
- Presents pertinent regulatory information to appropriate cross-functional teams.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent industry-related experience.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
- Extensive experience interfacing with government Agencies and Health Authority personnel.
- Able to deliver challenging messages effectively without compromising important business relationships.
- Experience working in a complex and matrixed environment.
- Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization.
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada device or combination product (device primary) experience preferred).
- US Class III device experience and familiarity with manufacturing processes/change control assessments is preferred.
- Demonstrated, forward-thinking strategic experience to accelerate programs or establish regulatory precedence using novel approaches is a plus.
- Global regulatory experience is a plus.
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
Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. Assures that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs.
- This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
- Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support. Provides direction and technical insight when necessary to ensure real-time guidance.
- Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel. May also serve as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
- Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
- Operates independently, with recognition of when to consult management. Makes decisions and plans for operations workflow, assignments within area of responsibility with minimal direction.
- Assists in the development, training, and mentoring of junior staff members.
- Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review. Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
- Demonstrates solid understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory.
- Presents pertinent regulatory information to appropriate cross-functional teams.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent industry-related experience.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
- Extensive experience interfacing with government Agencies and Health Authority personnel.
- Able to deliver challenging messages effectively without compromising important business relationships.
- Experience working in a complex and matrixed environment.
- Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization.
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada device or combination product (device primary) experience preferred).
- US Class III device experience and familiarity with manufacturing processes/change control assessments is preferred.
- Demonstrated, forward-thinking strategic experience to accelerate programs or establish regulatory precedence using novel approaches is a plus.
- Global regulatory experience is a plus.
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.