Regulatory Affairs Director

About this role

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