H-1B Visa Regulatory Affairs Jobs
Regulatory Affairs roles qualify as H-1B specialty occupations because they require at least a bachelor's degree in life sciences, pharmacy, or a related technical field. Employers in pharma, biotech, and medical devices file LCAs with the DOL before sponsoring, and many actively recruit internationally trained RA professionals.
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Get Access To All JobsABOUT 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.
JOB DESCRIPTION
The Manager, Regulatory Affairs Device, works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
Responsibilities:
- Prepares device regulatory product strategies with limited supervision.
- Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under limited supervision.
- Develops strategies for device meetings, manages preparation for agency meetings and manages content of pre-meeting submissions under limited supervision.
- Manages products and change control with an understanding of regulations and company policies and procedures with limited supervision. Analyzes and approves manufacturing change requests with limited supervision.
- Represents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in the regulatory climate. Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
- Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to RA.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
QUALIFICATIONS
- Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management. Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
- Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.
- Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
- Understanding of device/combination product regulations
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- Ability to travel up to [15] % of time
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
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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.
JOB DESCRIPTION
The Manager, Regulatory Affairs Device, works with internal and external partners to deliver products to patients. Prepares device regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for global regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Build and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA Device on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.
Responsibilities:
- Prepares device regulatory product strategies with limited supervision.
- Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
- Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under limited supervision.
- Develops strategies for device meetings, manages preparation for agency meetings and manages content of pre-meeting submissions under limited supervision.
- Manages products and change control with an understanding of regulations and company policies and procedures with limited supervision. Analyzes and approves manufacturing change requests with limited supervision.
- Represents Device Regulatory Affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions.
- Stays abreast of regulatory procedures and changes in the regulatory climate. Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision.
- Develops, implements, and documents policies and procedures within the regulatory affairs department under supervision of manager. Participates in initiatives internal to RA.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.
QUALIFICATIONS
- Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management. Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
- Knowledge of the ISO/CE process and global product registration process. Experience with eCTD tools and EDMS applications.
- Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products.
- Understanding of device/combination product regulations
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
- Ability to travel up to [15] % of time
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
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
See all 320+ Regulatory Affairs jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Regulatory Affairs roles.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs
Align your degree to FDA submission work
USCIS scrutinizes whether your degree field directly supports the specific RA duties in the job description. A chemistry or biology degree paired with regulatory coursework strengthens specialty occupation arguments far more than a general science background.
Search LCA filings before applying anywhere
Use Migrate Mate to filter employers by verified DOL LCA filing history in Regulatory Affairs. This surfaces companies that have already demonstrated H-1B sponsorship intent for this job code, cutting your search time significantly.
Target employers with dedicated RA departments
Standalone RA departments at mid-size pharma and Class II medical device companies sponsor more consistently than generalist consulting firms. O*NET classifies Regulatory Affairs Specialists under SOC 13-1041, which you can cross-reference against OFLC disclosure data.
Negotiate LCA filing into your offer timeline
The DOL must certify your LCA before USCIS receives the I-129 petition. Ask your employer to begin the LCA at least three weeks before your intended start date so certification doesn't delay your H-1B effective date.
Document foreign regulatory experience for RFEs
If you've worked with EMA, Health Canada, or TGA submissions, get official employer letters specifying submission types and your exact role. USCIS RFEs on RA petitions frequently challenge whether non-U.S. experience maps to the specialty occupation standard.
Verify your employer's E-Verify enrollment status
H-1B employers must be E-Verify participants to request cap-exempt processing through certain institutions or to rehire H-1B workers portably. Confirm enrollment before your final offer acceptance, not after signing.
Regulatory Affairs jobs are hiring across the US. Find yours.
Find Regulatory Affairs JobsRegulatory Affairs H-1B Visa: Frequently Asked Questions
Does a Regulatory Affairs job qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Specialist roles require theoretical and practical application of life sciences, pharmacy, chemistry, or engineering knowledge at the bachelor's degree level or higher. USCIS has approved H-1B petitions for RA roles across pharma, biotech, and medical device sectors. The employer's job description must specify degree requirements that are directly related to RA duties, not just broadly preferred.
Which industries sponsor H-1B visas most often for Regulatory Affairs professionals?
Pharmaceutical manufacturers, biologics companies, Class II and Class III medical device firms, and CROs file the largest volume of H-1B LCAs for Regulatory Affairs roles. Biotech startups preparing for IND or NDA submissions also sponsor frequently because RA expertise is scarce domestically. You can browse employers with active H-1B filing history for this role category on Migrate Mate.
What happens to my H-1B status if my employer loses an FDA contract or restructures the RA team?
You have a 60-day grace period after involuntary termination to find new H-1B sponsorship, change to another status, or depart the U.S. Under AC21 portability rules, if your I-140 has been approved and your I-485 has been pending for 180 days or more, you can port to a same or similar RA role with a new employer without losing your priority date.
How does the prevailing wage requirement affect H-1B sponsorship for Regulatory Affairs roles?
Your employer must pay at least the DOL prevailing wage for the RA job title, level, and work location. Prevailing wages are set at four wage levels based on experience and complexity. You can look up the applicable wage yourself using the OFLC Wage Search before negotiations. Employers who underpay relative to the certified LCA wage risk DOL audit and back-pay liability.
Can I transfer my H-1B to a new Regulatory Affairs employer mid-sponsorship?
Yes. H-1B portability lets you start working for a new H-1B employer as soon as the new I-129 petition is filed, not after approval. The new role must be in the same or a substantially similar RA occupational classification. Your new employer files a new LCA and I-129; you don't restart the lottery. This makes lateral moves within RA feasible without status gaps.
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