Sr. Manager, Regulatory Affairs

Job Description

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

About Us

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.