Regulatory Affairs Director
About The Position
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.
Requirements
- 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.
Nice To Haves
- Advanced degree (MS, PharmD, PhD) strongly preferred.
- Regulatory Affairs Certification (RAC) is beneficial.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1,001-5,000 employees
