H-1B Visa Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify as H-1B visa specialty occupations because they require at least a bachelor's degree in a directly related scientific or regulatory field. Pharma, biotech, and medical device companies regularly sponsor H-1B visas for this title, and many file for both initial three-year terms and six-year extensions.
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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 Senior Director Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Senior Director Regulatory Affairs Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Senior Director Regulatory Affairs
Align your credentials to SOC code 11-9041
USCIS maps Regulatory Affairs Director roles to this SOC code. Pull the O*NET profile for that code before interviews so you can speak to the specific knowledge areas USCIS expects when adjudicating specialty occupation petitions for this title.
Target employers with active LCA filing history
Use Migrate Mate to filter for companies that have filed Labor Condition Applications specifically for Regulatory Affairs titles. This tells you which employers have already cleared DOL certification for the role, not just who posts job listings.
Verify the prevailing wage tier before negotiating
Run the OFLC Wage Search for SOC 11-9041 in your target metro before you receive an offer. Your employer must pay at least the prevailing wage level certified on the LCA, so knowing the floor protects you during salary negotiations.
Document international regulatory submissions as evidence
USCIS RFEs for senior-level regulatory roles often challenge whether the position truly requires a specialized degree. Compile a record of FDA, EMA, or ICH submission projects you led, demonstrating that the job function is inseparable from scientific and regulatory expertise.
Confirm your employer files before the April cap deadline
H-1B registration opens in March for an October 1 start. If you're currently on OPT, confirm your prospective employer will submit the registration in time. A missed deadline means waiting a full year, so get written confirmation of their intended filing timeline early in the process.
Ask whether the role is cap-exempt
Some regulatory affairs roles at nonprofit research institutions, academic medical centers, or government contractors qualify for cap-exempt H-1B status through USCIS, allowing filing at any time without lottery selection. Confirm the employer's entity type before assuming you need to wait for the next cap cycle.
H-1B Visa Senior Director Regulatory Affairs: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role qualify as an H-1B specialty occupation?
Yes. USCIS consistently recognizes senior regulatory affairs positions as specialty occupations because the role requires theoretical and practical application of highly specialized regulatory science, typically requiring at least a bachelor's degree in pharmacy, chemistry, biology, or a related field. Directors overseeing FDA submissions, clinical regulatory strategy, or post-market compliance routinely receive H-1B approval under this standard.
Which industries sponsor H-1B visas most frequently for this role?
Pharmaceutical, biotechnology, and medical device companies account for the majority of H-1B sponsorships for Senior Director Regulatory Affairs titles. Contract research organizations and diagnostics manufacturers also file regularly. You can browse current openings at employers with verified LCA filing history for this title on Migrate Mate, which surfaces companies already cleared through the DOL certification process.
Can I transfer my H-1B to a new regulatory affairs employer mid-petition?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as the new I-129 petition is filed with USCIS, without waiting for approval, as long as your previous H-1B was approved and you've maintained valid status. Your new employer must file a new LCA certified by DOL before submitting the transfer petition.
Does a foreign regulatory affairs degree qualify for H-1B specialty occupation purposes?
Foreign degrees are accepted if they're equivalent to a U.S. bachelor's or higher in a directly related field. USCIS typically requires a credential evaluation from a recognized evaluation service to confirm equivalency. For Senior Director roles, degrees in pharmaceutical sciences, regulatory affairs, chemistry, or biology from accredited foreign institutions generally satisfy the educational requirement when properly evaluated.
How does the H-1B six-year cap apply to regulatory affairs professionals pursuing permanent residency?
The standard H-1B cap is six years, split into two three-year terms. If your employer files a PERM labor certification or I-140 immigrant petition at least 365 days before your six-year limit, you can extend your H-1B in one-year increments beyond that cap under the American Competitiveness in the 21st Century Act. Regulatory affairs professionals in the EB-2 or EB-3 categories commonly use this extension pathway while awaiting priority date movement.