Regulatory Affairs Director Jobs in USA with Visa Sponsorship
Regulatory Affairs Directors are strong H-1B sponsorship candidates. The role qualifies as a specialty occupation requiring advanced scientific or regulatory knowledge, and employers routinely sponsor because qualified candidates with FDA, EMA, or ICH experience are difficult to source domestically. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we do this with the utmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our groundbreaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.
ROLE AND RESPONSIBILITIES
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
What You'll Do
- Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
- Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.
- Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
- Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
- Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.
- Own the negotiations with health authorities and initiate and deliver key regulatory documents.
- Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
- Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
MINIMUM QUALIFICATIONS
- Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
- A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
- Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
- Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
PREFERRED QUALIFICATIONS
- Advanced degree preferred.
- Experience in Oncology (small molecules & biologics) is preferred.
- Prior experience with phase 3 design including end of phase 2 health authority interactions.
- Contribution to a regulatory approval including leading response team and labeling negotiations.
- Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
- Ability to work strategically within a business critical and high-profile development program.
- Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
Next Steps – Apply today! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
COMPENSATION
- Competitive Salary And Benefits Package On Offer
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The annual base salary for this position ranges from $186,232.80 - 279,349.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
DATE POSTED
17-Feb-2026
CLOSING DATE
30-Mar-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
INTRODUCTION
Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we do this with the utmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our groundbreaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.
ROLE AND RESPONSIBILITIES
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
What You'll Do
- Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
- Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.
- Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
- Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
- Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.
- Own the negotiations with health authorities and initiate and deliver key regulatory documents.
- Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
- Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
MINIMUM QUALIFICATIONS
- Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
- A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.
- Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
- Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
PREFERRED QUALIFICATIONS
- Advanced degree preferred.
- Experience in Oncology (small molecules & biologics) is preferred.
- Prior experience with phase 3 design including end of phase 2 health authority interactions.
- Contribution to a regulatory approval including leading response team and labeling negotiations.
- Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
- Ability to work strategically within a business critical and high-profile development program.
- Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
Next Steps – Apply today! AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
COMPENSATION
- Competitive Salary And Benefits Package On Offer
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The annual base salary for this position ranges from $186,232.80 - 279,349.20. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
DATE POSTED
17-Feb-2026
CLOSING DATE
30-Mar-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
How to Get Visa Sponsorship in Regulatory Affairs Director
Lead with your regulatory framework expertise
Employers sponsor when they can't find local talent. Emphasize specific frameworks you've worked within, such as FDA 21 CFR, ICH Q10, or EMA guidelines. Concrete regulatory experience signals you fill a genuine skills gap.
Target companies with active IND or BLA pipelines
Biotech and pharmaceutical companies with live investigational drug or biologics applications have urgent regulatory timelines. They're far more likely to sponsor quickly because regulatory delays cost millions and headcount gaps directly threaten approval schedules.
Highlight cross-border submission experience
Directors who've managed submissions across multiple jurisdictions simultaneously, such as FDA and Health Canada or EMA in parallel, are genuinely rare. This global dossier experience is a concrete reason employers initiate H-1B sponsorship for the right candidate.
Confirm your degree field aligns with the specialty occupation standard
USCIS requires your bachelor's degree or higher to be in a directly related field. Degrees in pharmacy, chemistry, biology, or regulatory science are strong. A business degree alone, without advanced scientific coursework, can complicate the petition.
Engage employers before H-1B lottery season closes
H-1B registrations open in March for an October start date. If you're targeting cap-subject employers, start conversations no later than January so the employer has time to engage immigration counsel and prepare your registration before the window closes.
Ask specifically about cap-exempt employer options
Hospitals, nonprofit research institutions, and universities are cap-exempt, meaning they can file H-1B petitions year-round without lottery risk. Regulatory roles exist in academic medical centers and research hospitals, and these employers often sponsor outside the annual cap.
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Get Access To All JobsFrequently Asked Questions
Does a Regulatory Affairs Director role qualify as an H-1B specialty occupation?
Yes, in most cases. USCIS evaluates whether the position normally requires a bachelor's degree or higher in a specific field. Regulatory Affairs Director roles typically require degrees in pharmacy, life sciences, chemistry, or a related discipline, and the complexity of FDA or EMA regulatory strategy satisfies the specialty occupation standard. Petition strength depends on how the employer's job description is written, so vague requirements can create problems.
How common is H-1B sponsorship for Regulatory Affairs Directors?
Sponsorship is relatively common in pharmaceutical, biotech, and medical device companies because qualified candidates with specific regulatory expertise, particularly in FDA submissions or international dossier management, are difficult to source locally. Mid-size and large companies with established legal infrastructure are the most reliable sponsors. You can browse current openings from sponsoring employers directly on Migrate Mate, which filters specifically for visa-sponsoring companies.
What degree does USCIS expect for a Regulatory Affairs Director H-1B petition?
USCIS looks for a degree in a field directly related to the job duties. Pharmacy, biochemistry, chemistry, biology, regulatory affairs, or a related life science field are strong matches. An MBA or general business degree alone is unlikely to support the petition unless paired with significant graduate-level scientific coursework. Some employers supplement a borderline degree with expert opinion letters from academic professionals attesting to field equivalency.
Can a Regulatory Affairs Director petition qualify for O-1A visa sponsorship instead?
Possibly, for senior directors with a documented record of distinction. The O-1A requires evidence of extraordinary ability, such as peer-reviewed publications, judging industry submissions, authoring regulatory guidance that was adopted, or speaking at major conferences. Directors at the VP level or above who've led landmark drug approvals may have a credible O-1A case. It's worth discussing with an immigration attorney if your H-1B lottery odds are a concern.
Does regulatory affairs experience outside the U.S. count toward H-1B eligibility?
Yes. Foreign regulatory experience, such as managing EMA, TGA, or Health Canada submissions, is directly relevant and strengthens an H-1B petition. USCIS evaluates credentials and experience in the context of the offered position, not where that experience was gained. Foreign degrees may require a credential evaluation by a NACES-member organization to confirm U.S. equivalency, which your employer's immigration attorney will typically arrange as part of the petition process.
What is the prevailing wage requirement for sponsored Regulatory Affairs Director 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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