H-1B Visa Regulatory Affairs Associate Jobs
Regulatory Affairs Associates help pharmaceutical, biotech, and medical device companies secure product approvals from the FDA and international agencies. The role qualifies as a specialty occupation under H-1B visa rules, requiring at least a bachelor's degree in a life sciences, pharmacy, or regulatory field. Many employers in this space have consistent H-1B filing histories.
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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
The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is 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. The Senior Manager assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.
Responsibilities:
- Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
- Serves as Health Authority (HA) liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion 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.
- Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
- May assist in the training of junior staff members.
- Key contributor responsible for 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.
- Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
- Presents pertinent regulatory information to appropriate cross-functional areas.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry-related experience.
- Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities.
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization. Able to deliver challenging messages effectively without compromising important business relationships.
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience working in a complex and matrix environment.
- Experience interfacing with government regulatory agencies.
- 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
The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is 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. The Senior Manager assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.
Responsibilities:
- Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports manager and/or Global Regulatory Lead (GRL) in the development & execution of the regulatory strategy. Assigned matters may have a moderate impact on business activities and operations.
- Serves as Health Authority (HA) liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion 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.
- Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
- May assist in the training of junior staff members.
- Key contributor responsible for 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.
- Supports the regulatory submission and approval process. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
- Presents pertinent regulatory information to appropriate cross-functional areas.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
- Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
Qualifications
- Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 5 years Regulatory, R&D, or equivalent industry-related experience.
- Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities.
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization. Able to deliver challenging messages effectively without compromising important business relationships.
- Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience working in a complex and matrix environment.
- Experience interfacing with government regulatory agencies.
- 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 239+ H-1B Visa Regulatory Affairs Associate Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Associate
Align your degree to regulatory science
USCIS evaluates whether your degree directly relates to regulatory affairs. A degree in pharmaceutical sciences, chemistry, biology, or a related field strengthens your specialty occupation argument far more than a general science or business credential.
Search LCA filings by SOC code
Regulatory Affairs Associates fall under SOC 13-1041. Use the OFLC Wage Search to filter Labor Condition Applications by that code and identify employers actively certifying wages for this role before you apply.
Target FDA-regulated industries specifically
Pharmaceutical, biologics, and Class II or III medical device companies file H-1B petitions for this role far more consistently than consumer goods or general manufacturing firms. Narrowing your search to these subsectors improves your odds of finding sponsors on Migrate Mate.
Document your product submission experience
When negotiating the offer, provide your employer with a clear summary of your regulatory submissions, such as INDs, NDAs, 510(k)s, or CE marks. This documentation directly supports the employer's specialty occupation argument in the I-129 petition.
Clarify whether the employer uses PERM later
Some regulatory affairs roles are designated as hard-to-fill and qualify for Schedule A, bypassing the PERM labor certification process if you pursue a green card. Ask the hiring team whether they've filed Schedule A petitions for this role before.
Verify employer E-Verify enrollment early
If you're on OPT STEM extension, your employer must be enrolled in E-Verify. Confirm enrollment before accepting an offer. Migrate Mate shows employer verification status alongside LCA filing history so you can check both in one place.
H-1B Visa Regulatory Affairs Associate: Frequently Asked Questions
Does a Regulatory Affairs Associate role qualify as a specialty occupation for H-1B purposes?
Yes, regulatory affairs roles typically qualify because they require specialized knowledge in life sciences, pharmacy, chemistry, or a related field, and employers generally require at least a bachelor's degree in those disciplines. USCIS reviews the job description and the employer's actual hiring practices, so the offer letter and job posting should reflect a specific degree requirement rather than listing a general science background as acceptable.
Which industries sponsor H-1B visas most consistently for this role?
Pharmaceutical companies, biologics manufacturers, and medical device firms that operate under FDA oversight file Labor Condition Applications for this title far more regularly than other sectors. Contract research organizations and regulatory consulting firms also sponsor, though their filing patterns vary. You can filter by industry and occupation code using the OFLC Wage Search or browse employer-verified listings on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA approval or downsizes the regulatory team?
If your employer terminates your position, USCIS provides a 60-day grace period during which you can find a new sponsoring employer. Your new employer must file an H-1B transfer petition before that window closes. Regulatory affairs professionals moving between FDA-regulated companies often qualify for cap-exempt transfers if the new employer is a nonprofit or government research entity.
Does my foreign regulatory experience with EMA or Health Canada count toward H-1B specialty occupation?
Yes, USCIS considers international regulatory experience when evaluating whether a position qualifies as a specialty occupation and whether you meet the qualifications. Experience with EMA submissions, CE marking, or Health Canada approvals demonstrates specialized knowledge that supports the petition. Document that experience in your resume and provide supporting letters from prior employers or clients when your employer files the I-129.
How do I find employers who actively sponsor H-1B visas for Regulatory Affairs Associate roles?
Migrate Mate surfaces employers with verified H-1B LCA filing history filtered to this specific occupation. You can identify pharmaceutical, biotech, and medical device companies that have filed Labor Condition Applications for regulatory roles, confirm their E-Verify enrollment status if you're on OPT, and apply directly through listings that already confirm sponsorship intent.