H-1B Visa Regulatory Affairs Manager Jobs
Regulatory Affairs Managers qualify for H-1B visa sponsorship as a specialty occupation requiring a bachelor's degree or higher in a directly related field such as regulatory science, pharmacy, or life sciences. Pharma, biotech, and medical device companies sponsor heavily for this role, and the work spans FDA submissions, compliance strategy, and cross-functional product approvals.
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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 Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Manager Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Manager
Align your credentials to specialty occupation requirements
USCIS evaluates whether your degree field directly relates to regulatory affairs work. A degree in regulatory science, pharmacy, chemistry, or biomedical engineering strengthens your petition far more than a general business degree, even with years of relevant experience.
Target employers with active LCA filing history
Search Migrate Mate to filter Regulatory Affairs Manager roles by employers who have filed Labor Condition Applications for this occupation. LCA history confirms an employer has already navigated DOL prevailing wage requirements for your exact job category.
Verify your role's SOC code before accepting an offer
Regulatory Affairs Managers are typically classified under SOC 11-9199 or 11-1021 depending on the employer. The SOC code determines the prevailing wage tier DOL uses, so confirm your employer's classification matches your actual duties before the LCA is filed.
Ask about cap-exempt employer status during interviews
Hospitals, universities, and certain nonprofit research institutions attached to higher education can sponsor H-1B visas outside the annual lottery cap. Regulatory affairs roles at academic medical centers or NIH-affiliated labs may let you skip the lottery entirely.
Use O*NET to document specialty occupation evidence
O*NET lists the typical education and knowledge requirements for regulatory affairs occupations. Print or save this profile before your petition is filed. Employers and attorneys use it to demonstrate that a bachelor's in a specific field is standard for the role.
Request premium processing if product timelines are tight
Regulatory affairs roles often tie directly to product launch or FDA submission deadlines. USCIS premium processing adjudicates the I-129 petition within 15 business days. Ask your employer to include it if your start date aligns with a critical regulatory milestone.
H-1B Visa Regulatory Affairs Manager: Frequently Asked Questions
Does a Regulatory Affairs Manager role qualify as a specialty occupation for H-1B purposes?
Yes. USCIS recognizes Regulatory Affairs Manager as a specialty occupation because the role typically requires a bachelor's degree or higher in a field such as regulatory science, pharmacy, chemistry, or a related life sciences discipline. Employers must document in the LCA and I-129 petition that the position demands specialized theoretical and practical knowledge tied to a specific degree field.
Which industries sponsor H-1B visas most consistently for Regulatory Affairs Managers?
Pharmaceutical, biotechnology, and medical device companies account for the largest share of H-1B sponsorships for this role, driven by FDA submission requirements and ongoing compliance obligations. Contract research organizations and in vitro diagnostics firms also sponsor regularly. You can browse verified sponsoring employers filtered by this job title on Migrate Mate.
How does the prevailing wage requirement affect Regulatory Affairs Manager H-1B filings?
Your employer must pay at least the DOL prevailing wage for a Regulatory Affairs Manager in the specific metropolitan area where you'll work. Wages are tiered by experience level, and the employer certifies this on the LCA before filing the H-1B petition. You can look up applicable wage levels by location and SOC code using the OFLC Wage Search.
Can a Regulatory Affairs Manager change employers while on H-1B status?
Yes, through H-1B portability under AC21. Once your initial H-1B petition has been approved and you've worked for the sponsoring employer, a new employer can file an H-1B transfer petition and you can begin work as soon as the receipt notice is issued. The new role must still qualify as a specialty occupation in regulatory affairs.
What documentation strengthens an H-1B petition for a Regulatory Affairs Manager role?
Strong petitions include a detailed job description specifying FDA regulatory submissions, compliance programs, or device approval processes; official transcripts showing a degree in a relevant field; and an employer letter explaining why the position requires that specific degree. If your title varies by employer, the O*NET occupation profile for this role category can serve as supporting evidence of degree-level requirements.