H-1B Visa Manufacturing Manager Jobs
Manufacturing Manager jobs with H-1B visa sponsorship require employers to certify a specialty occupation backed by a relevant bachelor's degree in engineering, operations, or a related field. Sponsored roles typically involve production planning, process engineering oversight, and cross-functional team leadership at the degree level.
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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
See all 201+ H-1B Visa Manufacturing Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Manufacturing Manager Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Manufacturing Manager
Align your credentials with specialty occupation standards
Pull the O*NET profile for Industrial Production Managers and map your degree and duties to the listed knowledge domains. USCIS scrutinizes whether your specific degree field directly relates to the managerial and technical responsibilities listed in the job description.
Target manufacturers with active LCA filing histories
Search Migrate Mate to identify manufacturing employers who have filed certified LCAs for manager-level roles in your target metro. Prioritized wage levels and consistent filing patterns signal an employer who understands the H-1B process and has cleared it before.
Request a site-specific LCA before accepting any offer
Each manufacturing facility where you'll work requires its own certified LCA listing that worksite address. If your offer covers multiple plants or a future relocation, confirm the employer plans to file separate LCAs for each location before you sign.
Use OFLC Wage Search to anchor your salary negotiation
Look up the prevailing wage for your SOC code and the county where the plant is located before negotiating. Your employer must pay at least the DOL-certified wage level in your LCA, so knowing the threshold prevents offers structured below what USCIS will approve.
Front-load technical duties in your job description draft
Work with your employer's HR team to ensure the written job description leads with engineering analysis, process improvement methodologies, and production system design rather than supervisory headcount. USCIS gives more weight to degree-level technical duties than to managerial oversight alone.
File premium processing if your start date is firm
Manufacturing roles often have hard production ramp-up deadlines. If your employer needs you on the floor by a specific date, request USCIS premium processing when they file the I-129 petition so you get a decision within the published expedited timeframe.
H-1B Visa Manufacturing Manager: Frequently Asked Questions
Does a Manufacturing Manager role qualify as an H-1B specialty occupation?
It qualifies when the employer structures the position around degree-level responsibilities such as process engineering, lean systems design, or industrial operations analysis. The role must normally require at least a bachelor's degree in engineering, manufacturing technology, industrial management, or a directly related field. Supervisory headcount alone is not sufficient; the technical and analytical duties must drive the degree requirement.
Which engineering or operations degrees are most defensible for a Manufacturing Manager H-1B petition?
Mechanical engineering, industrial engineering, manufacturing engineering, and operations management degrees carry the strongest direct-relationship argument because USCIS evaluates whether the degree field is specifically relevant to the role's duties. Business administration degrees are harder to defend unless the job description is heavily weighted toward quantitative operations analysis. Including a detailed specialty evaluation from a credentials assessor strengthens petitions involving non-U.S. degrees.
How do I find manufacturing employers who regularly sponsor H-1B visas for manager roles?
Browse Manufacturing Manager listings on Migrate Mate, which surfaces employers with verified H-1B LCA filing histories for operations and production management roles. Focusing on companies that have filed LCAs previously saves significant time because those employers already have established relationships with immigration counsel and understand the prevailing-wage and worksite requirements.
What happens to my H-1B status if the manufacturing plant I'm assigned to closes or relocates?
Your status is tied to the specific worksite listed on your certified LCA. If the facility closes, your employer must file an amended I-129 petition with a new LCA reflecting the replacement worksite before you begin working there. Working at an unlisted location, even temporarily during a transition, is a compliance violation. Confirm the amended petition timeline with your employer's immigration attorney before the move.
Can I transfer my H-1B to a new manufacturing employer mid-status?
Yes, an H-1B transfer allows you to begin working for a new sponsoring employer once the new I-129 petition is filed, without waiting for approval, under H-1B portability rules. The new employer must file their own LCA certified for your worksite and wage level. Your total authorized period counts against the 6-year maximum, so confirm how much time remains on your current approval before accepting a new offer.