H-1B Visa Regulatory Affairs Lead Jobs
Regulatory Affairs Lead roles qualify as H-1B visa specialty occupations under DOL's prevailing wage framework, requiring a bachelor's degree or higher in a directly related field such as regulatory science, chemistry, or life sciences. Employers in pharma, biotech, and medical devices sponsor H-1B petitions for this title regularly, and cap-exempt institutions add filing options outside the annual lottery.
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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 Lead Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Lead Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs Lead
Align your credentials to specialty occupation standards
USCIS evaluates whether your degree field directly relates to regulatory affairs. A chemistry, biology, or pharmaceutical sciences degree strengthens your petition. If your degree is in an adjacent field, document how your coursework maps to the core duties of a Regulatory Affairs Lead.
Target cap-exempt employers first
Hospitals, nonprofits attached to research institutions, and universities can file H-1B petitions year-round without lottery exposure. Regulatory affairs roles at academic medical centers or nonprofit research organizations qualify, cutting your wait from a full fiscal year to weeks.
Search LCA filing history on Migrate Mate
Filter by SOC code 13-1041 to see which pharma, biotech, and medical device employers have active Labor Condition Applications for regulatory roles. Employers with recent filings have confirmed infrastructure and willingness to sponsor, not just stated openness.
Verify prevailing wage tier before negotiating an offer
Pull the OFLC Wage Search for SOC 13-1041 in your target metro before accepting. Your employer's LCA must certify at least the Level II wage for your experience. Knowing the floor protects you from offers that create compliance risk at filing.
Confirm the employer's I-9 and E-Verify readiness
STEM OPT employers must be E-Verify enrolled, and many regulated pharma or device companies already are. Ask HR whether they're enrolled before the offer stage. Gaps in E-Verify enrollment delay your I-9 completion and complicate the transition from OPT to H-1B status.
Request premium processing if your OPT end date is close
USCIS adjudicates premium processing petitions within 15 business days. If your OPT expires within 60 days of your H-1B start date, ask your employer to elect premium processing so your approval arrives before you lose authorization to work.
H-1B Visa Regulatory Affairs Lead: Frequently Asked Questions
Does a Regulatory Affairs Lead role qualify as an H-1B specialty occupation?
Yes. USCIS classifies regulatory affairs positions as specialty occupations because the duties require at least a bachelor's degree in a directly related field such as regulatory science, life sciences, chemistry, or pharmacy. The O*NET profile for Regulatory Affairs Specialists supports this classification, and most employers use SOC code 13-1041 when filing the Labor Condition Application with DOL.
Which industries sponsor H-1B visas most consistently for Regulatory Affairs Lead positions?
Pharmaceutical manufacturers, biotech firms, and medical device companies sponsor the highest volume of H-1B petitions for regulatory affairs roles. Contract research organizations and in vitro diagnostics companies also file regularly. You can see which employers have active Labor Condition Applications for this role category by searching Migrate Mate, which surfaces DOL filing data by occupation and employer.
Can I transfer my H-1B to a new employer if my Regulatory Affairs Lead role changes scope?
Yes, H-1B portability under AC21 lets you start working for a new employer as soon as your transfer petition is filed, not after it's approved, provided your original petition has been approved and you've maintained valid status. If the new role involves materially different duties, your employer's attorney should document the specialty occupation basis again to avoid an RFE.
Does regulatory affairs work at a nonprofit hospital or university avoid the H-1B lottery?
It can. Cap-exempt status applies to H-1B petitions filed by qualifying nonprofits affiliated with research institutions and certain universities. If a hospital or academic medical center employs you in a Regulatory Affairs Lead capacity and meets the cap-exemption criteria under USCIS rules, your petition bypasses the lottery entirely and can be filed at any time of year.
What documentation does my employer need to file an H-1B petition for a Regulatory Affairs Lead role?
Your employer needs a certified Labor Condition Application from DOL, which covers prevailing wage compliance for the role's SOC code and work location. They'll also file Form I-129 with USCIS, supported by a detailed job duties letter, your academic credentials, and any professional licenses relevant to the regulatory function. Employers in FDA-regulated industries often already have H-1B filing experience, which accelerates the process.