Glaukos Corporation · 17 hours ago
Regulatory Affairs Director
Aliso Viejo, CA
Full-time
Hybrid
Director/Executive
9+ years expGlaukos Corporation is focused on transforming the standard of care for chronic eye diseases, and they are seeking a Sr. Manager of Regulatory Affairs to shape regulatory strategies for innovative drug/device combination products and prescription pharmaceuticals. In this leadership role, you will drive global regulatory strategies, oversee regulatory submissions, and engage with global health authorities to ensure compliance and support product development.
Health CareMedicalWellness
Responsibilities
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
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
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
Ensure regulatory deliverables are aligned with project timelines and milestones
Champion effective cross-functional coordination and regulatory best practices across departments
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
Qualification
Required
Bachelor's degree in a scientific discipline required
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
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
Preferred
Advanced degree (MS, PharmD, PhD) strongly preferred
Regulatory Affairs Certification (RAC) is beneficial
Company
Glaukos Corporation
At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.
1001-5000 employees
H1B Sponsorship
Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$121MKey Investors
Meritech Capital PartnersOrbiMed
2015-06-25IPO
2013-02-07Series F· $30M
2012-10-03Debt Financing· $6M
Leadership Team
Alex Thurman
Senior Vice President and Chief Financial Officer
Joseph Gilliam
President & Chief Operating Officer
Recent News
2025-12-17
Orange County Business Journal
2025-11-09
Company data provided by crunchbase