Green Card Regulatory Affairs Lead Jobs
Regulatory Affairs Lead roles qualify for EB-2 or EB-3 green card sponsorship through PERM labor certification, which permanently authorizes foreign professionals to work in the U.S. Employers file on your behalf, covering regulatory strategy, submissions management, and compliance oversight. Finding employers with active PERM filing history is the first step toward permanent residency sponsorship.
Find Green Card Regulatory Affairs Lead JobsOverview
Showing 5 of 209+ Regulatory Affairs Lead jobs
See all 209+ Regulatory Affairs Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs Lead roles.
Get Access To All JobsCompany 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
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 Regulatory Affairs Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Green Card Regulatory Affairs Lead Jobs.
Get Access To All JobsTips for Finding Green Card Sponsorship in Regulatory Affairs Lead
Document your regulatory credentials strategically
Gather degree transcripts, professional certifications like RAC, and performance reviews that demonstrate scope of regulatory submissions managed. PERM labor certification requires your employer to prove your qualifications match the role's minimum requirements exactly.
Target employers with active PERM filing history
Pharmaceutical, biotech, and medical device companies with dedicated regulatory affairs departments file PERM petitions regularly. Use Migrate Mate to filter Regulatory Affairs Lead roles by employers with documented green card sponsorship activity.
Understand EB-2 versus EB-3 classification for your background
If you hold a master's degree in a life sciences or regulatory field, you likely qualify for EB-2, which can mean shorter green card wait times for many nationalities. EB-3 covers bachelor's-level professionals and has no annual cap issues for most countries.
Verify specialty occupation alignment before accepting offers
Regulatory Affairs Lead roles typically qualify as specialty occupations under O*NET, requiring specialized knowledge of FDA or international regulatory frameworks. Confirm your job description explicitly references submission management or agency interaction to support the PERM filing.
Request employer-sponsored PERM early in offer negotiations
Once PERM is filed, your priority date locks in, protecting your place in the green card queue even if processing takes years. Raising sponsorship during offer negotiation, before you start, gives the employer time to begin DOL prevailing wage determination without delaying your start date.
Use OFLC Wage Search to benchmark your offer
DOL requires PERM-sponsored employers to pay the prevailing wage for your role and location. Cross-check your offered salary against the OFLC Wage Search before signing, since an offer below the DOL Level II or III threshold can invalidate the entire PERM filing.
Green Card Regulatory Affairs Lead: Frequently Asked Questions
Does a Regulatory Affairs Lead role qualify for EB-2 or EB-3 green card sponsorship?
Most Regulatory Affairs Lead positions qualify for both EB-2 and EB-3 depending on your degree level and your employer's job requirements. EB-2 applies when the role formally requires an advanced degree, which many senior regulatory positions do. EB-3 covers roles requiring at least a bachelor's degree. Your employer's attorney typically determines the classification based on the actual job description filed with DOL.
How does PERM green card sponsorship differ from H-1B for this role?
H-1B visa is a temporary nonimmigrant status requiring renewal every three years, with no guarantee of renewal and exposure to the annual lottery at the cap-subject level. PERM-based green card sponsorship leads to permanent residency with no status expiration. There is no annual lottery for employment-based green cards, and EB-3 has no cap on the number of applications, only on annual visa issuance per country. Regulatory professionals from most countries face shorter waits at the EB-3 level than Indian or Chinese nationals at EB-2.
How do I find Regulatory Affairs Lead jobs where the employer will sponsor a green card?
Search Migrate Mate to filter Regulatory Affairs Lead openings by employers with verified PERM sponsorship history. Not every job posting advertises green card sponsorship, so filtering by actual DOL filing records gives you a more reliable signal than relying on job descriptions alone. Pharmaceutical, medical device, and biotech companies with U.S. regulatory teams are the most active PERM filers in this occupation.
What does the PERM labor certification process look like for a Regulatory Affairs Lead?
Your employer must conduct a supervised recruitment process proving no qualified U.S. workers are available for the role at the offered wage. DOL reviews the application and, if certified, your employer files Form I-140 with USCIS to establish your immigrant visa petition. Current PERM processing at DOL runs several months for standard cases, and USCIS I-140 adjudication adds additional time. Your priority date is set when DOL receives the PERM application.
Can I change jobs after my employer files a PERM petition for my Regulatory Affairs Lead role?
Changing employers before your I-140 is approved generally restarts the PERM process with the new employer. Once your I-140 is approved and your priority date is more than 180 days old, federal law allows you to port to a same or similar regulatory affairs role with a new employer without losing your priority date. USCIS evaluates whether the new role is sufficiently similar to the original petition to allow portability.