H-1B Visa Regulatory Affairs Specialist Jobs
Regulatory Affairs Specialists qualify for H-1B visa sponsorship because the role meets the specialty occupation standard: a bachelor's degree or higher in life sciences, pharmacy, or a related field is typically required. Pharma, biotech, and medical device companies are among the most active H-1B filers for this title.
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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 Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Regulatory Affairs Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Regulatory Affairs Specialist
Align your degree to the role
USCIS requires a direct relationship between your degree field and the job duties. A degree in pharmacy, biochemistry, or regulatory science strengthens your petition. A business or general science degree may trigger an RFE without supporting documentation.
Target LCA-active employers on Migrate Mate
Search Migrate Mate to identify employers who have filed Labor Condition Applications for Regulatory Affairs Specialist roles. This filters for companies with verified H-1B sponsorship history in your specific occupation, not just general sponsorship willingness.
Verify prevailing wage before accepting an offer
Your offered salary must meet the DOL prevailing wage for your job title, industry, and work location. Run the OFLC Wage Search before negotiating to confirm your offer clears the Level I through Level IV wage tiers for your experience.
Document your regulatory credentials upfront
RAC certification, 21 CFR or ICH guideline experience, and submission history for FDA, EMA, or Health Canada all support the specialty occupation argument. Compile these before outreach so employers can assess petition viability early.
Ask about petition timing during interviews
H-1B cap-subject petitions must be filed by April 1 for an October 1 start. If your OPT or grace period ends before October, confirm whether the employer can file for cap-exempt status or structure your start date around the fiscal year cycle.
Cross-reference your SOC code in O*NET
Regulatory Affairs Specialists are classified under SOC 13-1041 or 19-1099 depending on the employer's job description. Confirming the correct SOC code before filing helps ensure the LCA wage level and job duties are accurately matched to your role.
H-1B Visa Regulatory Affairs Specialist: Frequently Asked Questions
Does a Regulatory Affairs Specialist role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS evaluates whether the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs roles tied to FDA submissions, drug approval processes, or device compliance typically meet this standard when the job description specifies a degree in pharmacy, life sciences, or a related discipline. Roles framed as generalist compliance positions may face additional scrutiny.
Which industries sponsor H-1B visas most often for Regulatory Affairs Specialists?
Pharmaceutical manufacturers, biotechnology companies, and medical device firms file the highest volume of H-1B LCAs for this occupation. Contract research organizations and regulatory consulting firms also sponsor, though at lower volumes. You can browse verified H-1B sponsoring employers in this field directly on Migrate Mate, filtered by occupation and filing history.
Can I transfer my H-1B to a new employer if I switch Regulatory Affairs roles?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as they file an H-1B transfer petition, without waiting for approval. The new employer must file a new I-129 with an updated LCA reflecting the new job title, duties, and work location. You don't need to restart the cap count, but the specialty occupation and prevailing wage requirements apply again.
Does my regulatory experience in another country count toward the H-1B specialty occupation requirement?
Foreign work experience can substitute for education under the three-for-one equivalency rule: three years of specialized experience may replace one year of a four-year degree. Experience with international regulatory frameworks like ICH guidelines, EMA submissions, or TGA processes is relevant, but USCIS will expect a credential evaluation from a NACES-recognized agency if your degree or experience is from outside the U.S.
What happens to my H-1B status if my employer's regulatory project ends and I'm laid off?
You have a 60-day grace period from your last day of employment to find a new sponsor, change to another visa status, or depart the U.S. During this window, you can't work but you remain in a valid period of authorized stay. Filing an H-1B transfer with a new employer before the grace period ends is the most common path to continuing work authorization without interruption.