Green Card Regulatory Affairs Associate Jobs
Regulatory Affairs Associate roles qualify for EB-2 and EB-3 green card sponsorship through PERM labor certification, which requires employers to document that no qualified U.S. worker is available before filing an I-140 petition on your behalf. Pharmaceutical, biotech, and medical device companies regularly sponsor foreign professionals in this compliance-driven field.
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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 210+ Green Card Regulatory Affairs Associate Jobs
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Get Access To All JobsTips for Finding Green Card Sponsorship as a Regulatory Affairs Associate
Verify your degree supports EB-2 eligibility
Regulatory Affairs Associate positions often require a life sciences or pharmacy degree. A master's or equivalent foreign credential positions you for EB-2 sponsorship, while a bachelor's degree still qualifies for EB-3 as a professional worker.
Target biotech and pharma companies with PERM history
Search OFLC PERM disclosure data to identify employers who have previously sponsored Regulatory Affairs roles. Companies filing PERM for this title regularly include medical device manufacturers and pharmaceutical firms with dedicated regulatory departments.
Find green card sponsors using Migrate Mate
Filter by job title and sponsorship type on Migrate Mate to surface Regulatory Affairs Associate openings at employers with active EB-2 and EB-3 filing history, saving you from applying to roles where sponsorship is unlikely.
Clarify sponsorship intent before accepting an offer
Ask directly whether the employer will initiate PERM within your first year. Some companies start the process immediately given Regulatory Affairs backlogs for certain nationalities, particularly for applicants from India or China.
Document your regulatory credentials before PERM begins
Gather official transcripts, RAC certification if applicable, and employment verification letters before your employer files PERM. DOL audits in this field often focus on whether your credentials match the advertised job requirements precisely.
Understand how prevailing wage affects your PERM case
Your employer must pay the DOL-certified prevailing wage for your Regulatory Affairs role and location. Check the OFLC Wage Search tool to confirm your offered salary meets Level I through Level IV thresholds before PERM is filed.
Green Card Regulatory Affairs Associate: Frequently Asked Questions
Does a Regulatory Affairs Associate role qualify for EB-2 or EB-3 sponsorship?
Both categories apply, depending on your credentials. EB-2 requires an advanced degree, so a master's in a life science, pharmacy, or regulatory discipline typically qualifies. EB-3 covers professionals with a U.S.-equivalent bachelor's degree. Most employers in pharma and biotech file under whichever category matches your education level.
How does PERM green card sponsorship differ from H-1B for a Regulatory Affairs Associate?
H-1B visa is a temporary nonimmigrant visa subject to an annual lottery, while PERM leads to permanent residency with no annual cap at the EB-3 professional level for most nationalities. PERM requires DOL labor market testing and takes 18 to 36 months from start to green card approval, but the outcome is lawful permanent residency rather than a renewable temporary status.
Which industries most commonly sponsor Regulatory Affairs Associates for green cards?
Pharmaceutical manufacturers, biotechnology companies, and medical device firms file PERM most frequently for Regulatory Affairs roles. Contract research organizations and food ingredient companies with FDA compliance teams also sponsor regularly. Employers in these sectors are accustomed to multi-year PERM timelines and build sponsorship into their hiring process.
How can I find Regulatory Affairs Associate jobs with green card sponsorship?
Migrate Mate lets you search specifically for Regulatory Affairs Associate roles at employers with EB-2 and EB-3 filing history, filtering out companies that only offer H-1B or no sponsorship at all. This narrows your search to employers who have already committed to the PERM process for this job title.
What happens to my green card case if I change employers during the PERM process?
If you change employers before the I-140 is approved, the PERM labor certification cannot be transferred and your new employer must restart the process from the beginning. Once your I-140 is approved and you've been in the priority date queue for 180 days, USCIS portability rules may allow you to change employers in a same or similar Regulatory Affairs role without losing your place in line.