H-1B Visa Regulatory Affairs Director Jobs
Regulatory Affairs Directors oversee compliance strategy across drug, device, or biotech product lifecycles, roles that USCIS consistently recognizes as specialty occupations requiring at least a bachelor's degree in a directly related scientific or regulatory field. H-1B visa sponsorship is common at large pharmaceutical, medical device, and contract research organizations.
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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 Director Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Regulatory Affairs Director
Document your regulatory credentials before applying
Gather degree transcripts, RAC certification if applicable, and submission histories tied to your name. USCIS scrutinizes specialty occupation claims for director-level roles, so evidence linking your specific credentials to the regulatory function strengthens the petition.
Target employers with active LCA filing history
Use Migrate Mate to filter Regulatory Affairs Director roles by employers who have filed Labor Condition Applications for this occupation code. Past LCA activity signals a company already understands the H-1B process for this specific function.
Verify prevailing wage before negotiating your offer
Look up the wage level for your SOC code and work location using the OFLC Wage Search before salary discussions. Your employer's LCA must certify at least the DOL prevailing wage, and accepting below that level invalidates the filing.
Confirm the role meets specialty occupation criteria
Review the O*NET profile for Regulatory Affairs Managers to understand how DOL categorizes education requirements. Director-level postings that list a degree as preferred rather than required create RFE risk, ask recruiters to confirm the job description before your employer files.
Ask about cap-exempt employer status during interviews
Hospitals, nonprofits affiliated with universities, and government research entities are cap-exempt, meaning you can file an H-1B petition outside the annual lottery. For Regulatory Affairs Directors at academic medical centers or NIH-funded labs, this eliminates lottery timing risk entirely.
Plan the I-129 timeline around your project deliverables
Standard USCIS processing runs several months, and regulatory submissions rarely pause for visa timelines. Confirm with your employer whether premium processing is available for your petition so your authorization start date aligns with product submission deadlines.
H-1B Visa Regulatory Affairs Director: Frequently Asked Questions
Does a Regulatory Affairs Director role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS evaluates whether the position normally requires at least a bachelor's degree in a specific field like pharmacy, biology, chemistry, or regulatory science. Director-level roles with strategic oversight of submissions and compliance programs typically satisfy this standard, particularly at pharmaceutical, biotech, and medical device companies. A well-drafted job description that ties duties to a specific degree field reduces RFE risk.
Which industries sponsor H-1B visas most often for Regulatory Affairs Directors?
Large pharmaceutical manufacturers, contract research organizations, medical device companies, and biotech firms are the most consistent sponsors for this role. These employers file LCAs routinely for regulatory functions because the work requires specialized scientific and compliance expertise. You can browse verified H-1B sponsoring employers in this field on Migrate Mate, filtered by occupation and filing history.
Can I transfer my H-1B to a new employer in a Regulatory Affairs Director role?
Yes. H-1B portability under AC21 allows you to start working for a new employer as soon as the transfer petition is filed, provided your current H-1B has been approved for at least 180 days. Your new employer must file a new I-129 petition with a certified LCA covering the Director role and your work location before your first day.
How does the H-1B lottery affect hiring timelines for this role?
If your target employer is cap-subject, your petition must be selected in the annual USCIS lottery before a full petition can be filed. Cap-exempt employers, including nonprofit research institutions and certain hospitals, bypass the lottery entirely. For cap-subject roles, employment typically begins October 1 of that fiscal year, so offers extended in Q1 or Q2 often involve a wait of six months or more.
What documentation should I prepare to support an H-1B petition for a Regulatory Affairs Director position?
You'll need official transcripts showing a qualifying degree, a credential evaluation if your degree is from outside the U.S., and documentation of any professional certifications such as RAC. Your employer's attorney will also need a detailed job description, your employment history showing progressive regulatory experience, and any published submissions or filings that demonstrate your direct role in regulatory strategy.