Regulatory Affairs Associate Jobs in USA with Visa Sponsorship
Regulatory Affairs Associates working in pharmaceuticals, medical devices, and biotech regularly receive H-1B and O-1 visa sponsorship. The role qualifies as a specialty occupation requiring a bachelor's degree or higher in a scientific or regulatory field, making employer sponsorship straightforward for qualified candidates. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
ROLE AND RESPONSIBILITIES
Brief team/department description: As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies. The person will play a crucial role in managing the lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Principle Responsibilities:
- Provide regulatory assistance with due diligence requests to support new business development activities.
- Support interaction with FDA and other regulatory agencies for assigned commercial products.
- Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
- Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
- Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
- Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
- Review and provide regulatory assessments for change control documentation.
- Provide regulatory support to regulatory leadership meetings and presentations.
- Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
- Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
- Other duties as assigned.
BASIC QUALIFICATIONS
- Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
- Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
- Combination of education and applicable job experience may be considered.
- Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
- Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
- Keen attention to detail.
- Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met.
- Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.
PHYSICAL & MENTAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time.
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear.
- May occasionally climb stairs and/or ride elevators.
- The employee must occasionally lift and/or move up to 25 pounds.
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices.
- Other miscellaneous job duties as required.
BENEFITS WE OFFER
- Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
- Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions.
- Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
- Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
- Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here. The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
INTRODUCTION
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
ROLE AND RESPONSIBILITIES
Brief team/department description: As part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Associate/Senior Associate will assist in preparing, review and submission regulatory filings to the FDA and other global health agencies. The person will play a crucial role in managing the lifecycle of IND, NDA, ANDA, etc. The Regulatory Affairs Associate/Senior Associate will report to the Associate Director, Regulatory Affairs and will work cross-functionally with other Azurity teams including but not limited to Technical Operation, Quality Assurance, Clinical Development, Medical Affairs.
Principle Responsibilities:
- Provide regulatory assistance with due diligence requests to support new business development activities.
- Support interaction with FDA and other regulatory agencies for assigned commercial products.
- Assist in compiling and authoring regulatory filings (IND, NDA, ANDA, etc.) and post marketing supplements for assigned products.
- Manage the timelines associated with regulatory submissions such as post-marketing periodic reports.
- Manage archival of regulatory submissions, regulatory correspondence and associated logs and tracking mechanisms.
- Provide regulatory guidance on requirements for post-approval changes, as required, for assigned products.
- Review and provide regulatory assessments for change control documentation.
- Provide regulatory support to regulatory leadership meetings and presentations.
- Keep abreast of current regulations and regulatory guidance, assessing impact to assigned products and internal processes.
- Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department.
- Other duties as assigned.
BASIC QUALIFICATIONS
- Minimum of Bachelor of Science or preferred advanced health care discipline degree (PharmD, PhD, Master of Science, etc.) or equivalent qualification.
- Minimum of 3 years in the pharmaceutical industry with at least 1 of those years in regulatory affairs.
- Combination of education and applicable job experience may be considered.
- Excellent organizational, interpersonal, verbal, and written communication skills, strong grammar, and proofreading/editing skills, and MS Office skills are required.
- Ability to work independently with minimal supervision in a fast-paced deadline driven environment.
- Keen attention to detail.
- Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and regulatory requirements are met.
- Ability to successfully communicate, negotiate and influence regulatory strategy to key stakeholders.
PHYSICAL & MENTAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time.
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear.
- May occasionally climb stairs and/or ride elevators.
- The employee must occasionally lift and/or move up to 25 pounds.
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices.
- Other miscellaneous job duties as required.
BENEFITS WE OFFER
- Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent.
- Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.
- Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you.
- Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of.
- Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions.
- Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%.
- Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date.
- Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge.
- Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.
- Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work.
The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here. The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).
How to Get Visa Sponsorship as a Regulatory Affairs Associate
Target FDA-regulated industries first
Pharmaceutical, biotech, and medical device companies have established immigration programs and sponsor Regulatory Affairs Associates at higher rates than other sectors. These employers file LCAs and H-1B petitions routinely, which means faster internal approval processes for sponsorship requests.
Document your degree's relevance to the role
USCIS requires a direct relationship between your degree field and the job duties. Degrees in life sciences, chemistry, pharmacology, or biomedical engineering map cleanly. If your degree is adjacent, gather course transcripts that demonstrate regulatory, scientific, or compliance coursework.
Highlight submission experience in your resume
Employers sponsoring H-1B petitions need to prove the role requires specialized knowledge. Listing specific submissions, such as 510(k)s, INDs, or CTAs, strengthens both your candidacy and the specialty occupation argument USCIS evaluates during petition review.
Apply to companies with existing RAA headcount
Companies that already employ Regulatory Affairs Associates on H-1B status have proven their HR and legal teams can handle the process. Joining an established regulatory department significantly reduces friction compared to being the first sponsored employee in that function.
Understand the H-1B lottery timing before accepting offers
If you need cap-subject H-1B sponsorship, registration opens in March for an October 1 start. Clarify your current status and timeline with each employer early in interviews so both parties understand what bridging arrangements, such as OPT extension, may be needed.
Consider contract and CRO roles as entry points
Contract Research Organizations and staffing agencies that place regulatory professionals often sponsor visas and can be faster to move than large pharma legal teams. A contract role with sponsorship builds U.S. regulatory experience that strengthens future full-time petitions.
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Get Access To All JobsFrequently Asked Questions
Does a Regulatory Affairs Associate role qualify as an H-1B specialty occupation?
Yes. Regulatory Affairs Associate positions consistently qualify as H-1B specialty occupations because they require at least a bachelor's degree in a specific scientific or regulatory field, life sciences, chemistry, biomedical engineering, or pharmacy are the most common. USCIS has approved thousands of H-1B petitions for this job title across pharmaceutical and medical device companies. The role's technical complexity and degree requirement make denial on specialty occupation grounds uncommon when the petition is properly documented.
Which visa types do Regulatory Affairs Associates most commonly receive sponsorship for?
H-1B is the most common visa for Regulatory Affairs Associates. Candidates with extraordinary achievement in regulatory science, such as published research or leadership on major submissions, sometimes qualify for O-1A. Australians with the right credentials should explore the E-3 visa, which skips the H-1B lottery entirely and is easier for employers to process. Use Migrate Mate to filter job listings by visa type and identify which sponsoring employers are actively hiring.
Do employers in pharma and biotech routinely sponsor Regulatory Affairs Associates?
Yes, sponsorship rates are high in this field. Large pharmaceutical companies, mid-size biotechs, and medical device manufacturers all hire internationally and have immigration counsel on retainer. DOL LCA disclosure data consistently shows companies like Johnson & Johnson, Pfizer, and Abbott filing for Regulatory Affairs roles. Smaller companies and startups sponsor less predictably, so it is worth confirming sponsorship willingness early in the interview process.
Can I qualify for Regulatory Affairs Associate sponsorship with a non-science degree?
It depends on the specific degree and how closely it relates to the regulatory function. A degree in public health, law, or even engineering can support a petition if your coursework or professional experience maps to regulatory compliance. USCIS evaluates whether the degree is in a directly related field. A credential evaluation and a strong job description tying your background to regulatory requirements will be necessary. An immigration attorney can assess your specific profile before you apply.
What documents does my employer need to sponsor my H-1B as a Regulatory Affairs Associate?
Your employer needs to file a Labor Condition Application with the Department of Labor, then submit Form I-129 to USCIS with supporting documentation. That includes a detailed job description outlining the regulatory duties and degree requirements, proof of your qualifications, and evidence the employer can pay the prevailing wage. For Regulatory Affairs roles, employers often include examples of the regulatory submissions the position manages to strengthen the specialty occupation argument.
What is the prevailing wage requirement for sponsored Regulatory Affairs Associate jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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