Regulatory Affairs Manager Jobs in USA with Visa Sponsorship
Regulatory Affairs Manager roles qualify as specialty occupations under the H-1B visa, making them strong candidates for visa sponsorship. Employers in pharma, biotech, and medical devices regularly file LCAs for this title. Your degree field, not just your experience, determines which visa pathways are open to you. For detailed occupation requirements, see the O*NET profile.
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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, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice.
Responsibilities:
- Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations 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.
- Responds to global regulatory information requests.
- Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
- Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
- Represents CMC 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 regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.
- Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC.
- Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.
Qualifications
- Required Education: Bachelor’s degree in pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
- Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 8 years’ pharmaceutical experience.
- Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
- Note: Higher education may compensate for years of experience.
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, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice.
Responsibilities:
- Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations 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.
- Responds to global regulatory information requests.
- Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
- Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
- Represents CMC 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 regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization.
- Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC.
- Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.
Qualifications
- Required Education: Bachelor’s degree in pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject.
- Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 8 years’ pharmaceutical experience.
- Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment.
- Strong oral and written communication skills.
- Note: Higher education may compensate for years of experience.
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
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Get Access To All JobsTips for Finding Visa Sponsorship as a Regulatory Affairs Manager
Align your degree to your specialty
USCIS scrutinizes whether your degree field directly relates to regulatory affairs. Life sciences, chemistry, pharmacy, and biomedical engineering degrees clear this bar cleanly. A business degree alone can trigger a Request for Evidence, so document any supplemental coursework or certifications upfront.
Target FDA-regulated industry employers first
Pharma, biotech, medical device, and food manufacturing companies file LCAs for Regulatory Affairs Managers far more consistently than general industry. Focus your search on employers with active FDA submissions or ISO certification requirements, where this role is operationally non-negotiable.
Search Migrate Mate for verified sponsoring employers
Regulatory Affairs Manager is a niche title, so verifying which employers actually sponsor matters. Migrate Mate lists U.S. employers with verified LCA filing history for this role, so you can target companies with a real sponsorship track record rather than guessing from job postings.
Confirm the prevailing wage tier before negotiating
Your employer's LCA must certify a wage at the correct DOL level for your location and experience. Use the OFLC Wage Search to look up the prevailing wage for Regulatory Affairs Managers in your target metro before accepting any offer, so there are no surprises at the LCA stage.
Get your foreign credentials evaluated early
If your degree is from outside the U.S., a credential evaluation from a NACES-member service is typically required before your employer files. Regulatory affairs roles in pharma often require this during the PERM labor certification process, and delays here can push back your entire timeline by weeks.
Clarify remote work arrangements in your LCA
If you'll work remotely or across multiple sites, your employer must file a separate LCA for each worksite location. This is a common oversight in regulatory roles where employees split time between a lab, a corporate office, and client facilities, and USCIS treats it as a compliance violation if missed.
Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS treats Regulatory Affairs Manager as a specialty occupation when the employer can demonstrate the role normally requires a bachelor's degree or higher in a directly related field, such as life sciences, pharmacy, or engineering. Generalist management roles at smaller companies can face more scrutiny, so the job description needs to reflect technical regulatory responsibilities, not just oversight duties.
Which visa types support sponsorship for Regulatory Affairs Managers?
The H-1B is the most common path, covering specialty occupation roles and requiring an employer to file a Labor Condition Application with DOL. Australian nationals can use the E-3 visa, which follows a similar specialty occupation standard but has no lottery. Canadian and Mexican nationals may qualify under TN visa if the role maps to an eligible USMCA profession. F-1 students can also work in this role during OPT or STEM OPT if the position relates to their degree.
How do I find Regulatory Affairs Manager jobs that offer visa sponsorship?
Migrate Mate lists employers with verified LCA filing history for Regulatory Affairs Manager roles, so you can focus on companies that have sponsored this title before rather than relying on job posting language that may be inaccurate. Pharma, biotech, and medical device companies dominate sponsorship for this title, and searching by industry alongside role type gives you the most relevant results.
Does my degree field matter for a Regulatory Affairs Manager H-1B application?
Your degree field matters significantly. USCIS requires a direct relationship between your degree and the job duties. Life sciences, pharmacy, chemistry, biomedical engineering, and regulatory science degrees clear the specialty occupation test reliably. If your degree is in a less directly related field, your employer may need to submit additional documentation showing the role's theoretical and practical requirements align with your academic background.
Can a Regulatory Affairs Manager qualify for a green card through the EB-2 or EB-3 category?
Yes. Most Regulatory Affairs Manager positions qualify under EB-2 if the role requires an advanced degree, or EB-3 for skilled workers requiring at least two years of experience. The employer typically initiates the PERM labor certification process with DOL before filing the I-140 petition with USCIS. Applicants from India and China face significant priority date backlogs in both categories, while most other nationalities move through the process more quickly.
What is the prevailing wage requirement for sponsored Regulatory Affairs Manager jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.