Green Card Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify for EB-2 sponsorship when they require an advanced degree in a life sciences or regulatory discipline, and many large pharmaceutical, biotech, and medical device employers run active PERM pipelines for this title. Your path to a green card starts with finding an employer already set up to sponsor.
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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 209+ Green Card Senior Director Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Green Card Senior Director Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding Green Card Sponsorship in Senior Director Regulatory Affairs
Verify your degree meets EB-2 requirements
An advanced degree in regulatory affairs, pharmacy, biochemistry, or a related life sciences field is the standard EB-2 baseline. A bachelor's plus five years of progressive regulatory experience can substitute if your employer documents the equivalency during PERM.
Target employers with active PERM filings
Use the OFLC Wage Search to confirm whether a prospective employer has recently filed PERM applications for regulatory affairs titles. Companies with existing PERM infrastructure move faster and understand the documentation burden for senior-level roles.
Search green card sponsoring jobs on Migrate Mate
Migrate Mate filters Senior Director Regulatory Affairs openings by green card sponsorship history, so you're applying to employers who have already navigated PERM for comparable roles rather than introducing the process to an unprepared HR team.
Align your FDA submission record with job requirements
PERM requires the employer to demonstrate no qualified U.S. worker is available. Your NDA, BLA, or 510(k) submission history, documented with dates and regulatory outcomes, strengthens the case that your credentials meet genuinely specialized requirements.
Negotiate green card sponsorship timing before accepting an offer
Ask during final-round negotiations whether the company will initiate PERM within your first year. Senior director offers with equity or sign-on bonuses are strong leverage points to formalize a sponsorship commitment before you sign.
Understand EB-2 versus EB-3 before PERM is filed
Your employer chooses the category when filing the I-140. EB-2 requires documenting an advanced degree or equivalent; EB-3 applies if the role is defined at the bachelor's level. The choice affects your priority date and wait time, so confirm it with your employer before DOL filing.
Green Card Senior Director Regulatory Affairs: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role typically qualify for EB-2 or EB-3 sponsorship?
Most Senior Director Regulatory Affairs positions qualify for EB-2 because employers routinely require a master's degree or a bachelor's degree with substantial progressive experience in a regulatory discipline. If the employer defines the minimum requirement at the bachelor's level without an advanced degree requirement, EB-3 may apply instead. The PERM labor certification filing locks in the category, so confirm the degree requirement with your employer before the process begins.
How does green card sponsorship differ from H-1B for this role?
H-1B visa sponsorship is temporary, capped at 85,000 per fiscal year, and subject to a lottery for most applicants. EB-2 and EB-3 green card sponsorship through PERM is permanent residency, has no annual lottery, and results in an I-140 immigrant petition tied to your priority date rather than a temporary status. The PERM process itself takes longer to initiate, typically six months to two years from job offer to I-140 approval, but the outcome is a path to lawful permanent residency rather than a visa renewal cycle.
What does the PERM labor certification process look like for a senior regulatory role?
Your employer files the PERM application with DOL after completing a mandatory recruitment period, usually 30 to 60 days of documented U.S. candidate outreach. For a Senior Director Regulatory Affairs role, the job requirements posted during recruitment must match exactly what appears on the PERM application. DOL audits are more common for senior titles, so employers with in-house immigration counsel or prior PERM experience for regulatory roles handle this more efficiently.
How can I find Senior Director Regulatory Affairs jobs where the employer already sponsors green cards?
Migrate Mate lets you filter regulatory affairs roles specifically by green card sponsorship history, which means you're seeing employers who have already filed PERM applications for comparable titles. Applying to companies with an established sponsorship track record significantly reduces the risk that your offer falls through because the employer is unfamiliar with the PERM process or unwilling to commit to the timeline.
Can my employer start the PERM process while I'm on H-1B status?
Yes. Many foreign professionals in Senior Director Regulatory Affairs roles begin the PERM process while maintaining H-1B status. Filing PERM and an I-140 does not require you to change status, and once your I-140 is approved with a current priority date, you can file for adjustment of status to a green card through USCIS without leaving the U.S. Your H-1B can be extended beyond the standard six-year cap once your I-140 is approved and your priority date is within one year of becoming current.