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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GLAUKOS - Sr. Manager, Regulatory Affairs
LOCATION: Aliso Viejo, CA
Work Arrangement: Hybrid work schedule
How Will You Make an Impact?
Be at the forefront of innovation – shape regulatory strategies that bring breakthrough therapies and life-changing technologies to patients around the world. At Glaukos, We’ll Go First – and as our next Sr. Manager, Regulatory Affairs, so will you. In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug/device combination products and prescription pharmaceuticals. You will lead the preparation of high-quality regulatory submissions, ensure cross-functional alignment, and help shape product development, regulatory approvals, and long-term compliance. Your work will help bring pioneering treatments to patients globally. At Glaukos, we’re a community of innovators focused on transforming the standard of care for chronic eye diseases. With a pioneering spirit and patient-first mindset, we are advancing bold new treatments that improve lives. Join us as we lead the way in sight-saving innovation.
What Will You Do?
Drive Regulatory Strategy and Execution:
- Lead and implement global regulatory strategies for combination products and pharmaceuticals in alignment with development goals.
- Provide strategic regulatory input to interdisciplinary teams on development plans, labeling, and compliance documentation.
- Review and approve internal documents supporting product development and lifecycle activities.
- Represent Regulatory Affairs in cross-functional meetings and project reviews.
- Mentor and guide junior regulatory team members.
Prepare and Submit Regulatory Documentation:
- Oversee the planning, authoring, and coordination of high-quality global submissions (e.g., INDs, CTAs, NDAs, supplements, annual reports).
- Collaborate with subject matter experts to ensure submissions are technically sound, timely, and fully compliant.
- Identify and resolve technical and regulatory challenges during submission development.
Engage with Global Regulatory Authorities:
- Support and lead interactions with U.S. FDA, EMA, and other global health authorities.
- Draft and contribute to briefing packages and manage submission-related communications.
Collaborate and Lead Across Projects:
- Ensure regulatory deliverables are aligned with project timelines and milestones.
- Champion effective cross-functional coordination and regulatory best practices across departments.
Stay Informed and Elevate Best Practices:
- Stay current on FDA, ICH, and EU regulatory changes and trends impacting combination product and pharmaceutical development.
- Help refine internal regulatory systems, submission templates, and document standards.
- Share and implement best practices across the team.
How Will You Get Here?
Education:
- Bachelor’s degree in a scientific discipline required.
- Advanced degree (MS, PharmD, PhD) strongly preferred.
Experience:
- 9+ years of experience in the life sciences industry, including 6+ years in Regulatory Affairs focused on pharmaceuticals and/or combination products.
- Proven experience preparing, leading, and submitting INDs, NDAs, CTAs, and associated amendments and reports.
- Prior involvement in regulatory interactions with FDA and/or EMA.
Knowledge, Skills, and Competencies:
- Deep knowledge of 21 CFR, FDA/ICH guidelines, GxPs, and applicable EU regulatory frameworks.
- Excellent written and verbal communication skills with a collaborative and solutions-oriented mindset.
- Strong critical thinking, project management, and leadership skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with document management systems a plus.
- Regulatory Affairs Certification (RAC) is beneficial.
GKOSUS
INTRODUCTION
GLAUKOS - Sr. Manager, Regulatory Affairs
LOCATION: Aliso Viejo, CA
Work Arrangement: Hybrid work schedule
How Will You Make an Impact?
Be at the forefront of innovation – shape regulatory strategies that bring breakthrough therapies and life-changing technologies to patients around the world. At Glaukos, We’ll Go First – and as our next Sr. Manager, Regulatory Affairs, so will you. In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug/device combination products and prescription pharmaceuticals. You will lead the preparation of high-quality regulatory submissions, ensure cross-functional alignment, and help shape product development, regulatory approvals, and long-term compliance. Your work will help bring pioneering treatments to patients globally. At Glaukos, we’re a community of innovators focused on transforming the standard of care for chronic eye diseases. With a pioneering spirit and patient-first mindset, we are advancing bold new treatments that improve lives. Join us as we lead the way in sight-saving innovation.
What Will You Do?
Drive Regulatory Strategy and Execution:
- Lead and implement global regulatory strategies for combination products and pharmaceuticals in alignment with development goals.
- Provide strategic regulatory input to interdisciplinary teams on development plans, labeling, and compliance documentation.
- Review and approve internal documents supporting product development and lifecycle activities.
- Represent Regulatory Affairs in cross-functional meetings and project reviews.
- Mentor and guide junior regulatory team members.
Prepare and Submit Regulatory Documentation:
- Oversee the planning, authoring, and coordination of high-quality global submissions (e.g., INDs, CTAs, NDAs, supplements, annual reports).
- Collaborate with subject matter experts to ensure submissions are technically sound, timely, and fully compliant.
- Identify and resolve technical and regulatory challenges during submission development.
Engage with Global Regulatory Authorities:
- Support and lead interactions with U.S. FDA, EMA, and other global health authorities.
- Draft and contribute to briefing packages and manage submission-related communications.
Collaborate and Lead Across Projects:
- Ensure regulatory deliverables are aligned with project timelines and milestones.
- Champion effective cross-functional coordination and regulatory best practices across departments.
Stay Informed and Elevate Best Practices:
- Stay current on FDA, ICH, and EU regulatory changes and trends impacting combination product and pharmaceutical development.
- Help refine internal regulatory systems, submission templates, and document standards.
- Share and implement best practices across the team.
How Will You Get Here?
Education:
- Bachelor’s degree in a scientific discipline required.
- Advanced degree (MS, PharmD, PhD) strongly preferred.
Experience:
- 9+ years of experience in the life sciences industry, including 6+ years in Regulatory Affairs focused on pharmaceuticals and/or combination products.
- Proven experience preparing, leading, and submitting INDs, NDAs, CTAs, and associated amendments and reports.
- Prior involvement in regulatory interactions with FDA and/or EMA.
Knowledge, Skills, and Competencies:
- Deep knowledge of 21 CFR, FDA/ICH guidelines, GxPs, and applicable EU regulatory frameworks.
- Excellent written and verbal communication skills with a collaborative and solutions-oriented mindset.
- Strong critical thinking, project management, and leadership skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with document management systems a plus.
- Regulatory Affairs Certification (RAC) is beneficial.
GKOSUS
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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.