E-3 Visa Regulatory Affairs Director Jobs
Regulatory Affairs Director roles in the U.S. qualify as E-3 specialty occupations, requiring a degree in life sciences, pharmacy, or a related regulatory field. Australian professionals can secure E-3 visa sponsorship without entering a lottery, and the visa renews indefinitely as long as you hold a qualifying position.
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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 Director Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Regulatory Affairs Director Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship in Regulatory Affairs Director
Translate your TGA credentials for U.S. hiring managers
Frame your Therapeutic Goods Administration experience explicitly in FDA and ICH framework terms on your resume. U.S. employers assess regulatory fluency by the acronyms and dossier types you cite, and TGA-only language often gets filtered out before interviews.
Target employers with active FDA submission histories
Search DOL LCA disclosure data for companies that have filed Labor Condition Applications under regulatory affairs job titles. Employers already familiar with federal submission workflows are far more likely to understand and support the E-3 visa sponsorship process.
Search Migrate Mate to find sponsoring employers
Use Migrate Mate to filter Regulatory Affairs Director roles by employers who have sponsored E-3 or H-1B visas before. This removes the guesswork of cold-applying to companies that have never navigated visa sponsorship for this role type.
Clarify your specialty occupation case before applying
Regulatory Affairs Director roles generally qualify as specialty occupations, but your offer letter must describe duties requiring a specific degree field. Vague job descriptions linking any bachelor's to the role can create problems at the consulate, so request precise language from your employer before the LCA is filed.
Secure your LCA before negotiating your start date
DOL must certify your Labor Condition Application before you can attend your visa interview. LCA processing typically runs seven business days, but your employer's legal or HR team needs lead time. Build at least three weeks of buffer between your accepted offer and your proposed first day.
Use Migrate Mate's E-3 filing service for the full process
Once you have an offer, use Migrate Mate's E-3 filing service to handle your LCA submission, DS-160, and consulate preparation. Regulatory affairs cases often involve specialized degree-to-role matching that benefits from expert review before your interview documents are finalized.
E-3 Visa Regulatory Affairs Director: Frequently Asked Questions
How do I find Regulatory Affairs Director jobs with E-3 visa sponsorship?
Use Migrate Mate to search Regulatory Affairs Director roles filtered by employers with E-3 or H-1B sponsorship history. Generic job boards don't surface visa sponsorship willingness, so you end up cold-applying to companies that have never sponsored a work visa. Migrate Mate surfaces employers already familiar with the process, which significantly shortens your search timeline.
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 Director role qualify as an E-3 specialty occupation?
Yes, in most cases. USCIS and consular officers assess whether the position normally requires at least a bachelor's degree in a specific field such as life sciences, pharmacy, chemistry, or regulatory science. The role's written duties must reflect that requirement. Generic language like 'bachelor's degree in a related field' can weaken the case, so work with your employer to ensure the offer letter and LCA describe the position with enough specificity.
How does the E-3 visa compare to the H-1B for Regulatory Affairs Director roles?
The E-3 has no lottery and no annual cap, so you can apply at any point in the year after receiving an offer. H-1B registrations open once a year and are subject to random selection, meaning qualified candidates are frequently excluded. For Australian nationals, the E-3 is almost always the faster and more predictable path to a U.S. Regulatory Affairs Director role.
Can I change employers or move between regulatory roles while on an E-3?
Yes, but each employer change requires a new LCA and, if you're outside the U.S., a new visa stamp. If you're already in the U.S. in valid E-3 status, you can start with a new employer once the new LCA is certified, without waiting for a new visa stamp if your current stamp is still valid. Promotions within the same company that substantially change your job duties may also require a new LCA.