Sr. Manager, Regulatory Affairs

GLAUKOS - Sr. Manager, Regulatory Affairs - Pharmaceuticals | Drug/Device Combination Products

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"!

As the Sr. Manager, Regulatory Affairs, you will support the execution of global regulatory strategies for innovative drug-device combination products and prescription pharmaceuticals. You will contribute to the preparation and submission of high-quality regulatory documentation and help ensure alignment with internal teams and global regulatory requirements. Your work will directly shape product development, approvals, and ongoing compliance efforts.

What will you do?

Support Regulatory Strategy Execution:

• Implement global regulatory strategies for combination products and pharmaceuticals in alignment with cross-functional team goals.
• Participate in interdisciplinary project teams, providing regulatory input on development plans, labeling, and compliance documentation.
• Review and contribute to internal documentation supporting product development and lifecycle activities.
• Coordinate with Clinical, R&D, and Quality to ensure design control and clinical requirements are met.
• Assist in mentoring junior regulatory team members.

Prepare and Support Regulatory Submissions:

• Contribute to the preparation, review, and coordination of global regulatory submissions (e.g., INDs, CTAs, NDAs, supplements, annual reports).
• Ensure submissions are complete, accurate, and in compliance with all relevant guidelines and timelines.
• Help identify and resolve technical or strategic issues in collaboration with subject matter experts.

Engage with Regulatory Authorities:

• Support interactions with U.S. FDA and EMA related to regulatory submissions, inquiries, and responses.
• Assist in drafting briefing documents and managing submission-related communications.

Collaborate Across Projects:

• Work within multi-disciplinary teams to support project goals and regulatory timelines.
• Monitor progress and help maintain alignment between regulatory tasks and broader program deliverables.

Stay Informed and Promote Best Practices:

• Stay current on regulatory requirements, guidance, and industry trends relevant to pharmaceuticals and combination products.
• Contribute to the development and improvement of internal regulatory processes, templates, and submission standards.

How will you get here?

Education:

• Bachelor's degree in a scientific discipline required.
• Advanced degree (MS, PharmD, PhD) preferred.

Experience:

• 9+ years of industry experience, including 5+ years in regulatory affairs for pharmaceuticals and/or combination products.
• Experience preparing and supporting regulatory submissions (e.g., IND, NDA, CTA, supplements, amendments).
• Familiarity with U.S. FDA and EU regulatory requirements.

Skills & Competencies:

• Solid understanding of FDA regulations, ICH guidelines, GxPs, and applicable EU regulatory frameworks.
• Strong written and verbal communication skills with the ability to collaborate across functions.
• Attention to detail and ability to manage multiple tasks in a dynamic environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint); document management systems experience a plus.
• Regulatory Affairs Certification (RAC) is beneficial.