Senior Manager Regulatory Affairs

Job Description

Sr. Manager, Regulatory Affairs

Aliso Viejo, CA

Hybrid work schedule

Full Time / Direct Hire

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 the company, 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 our client as they 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 :

Engage with Global Regulatory Authorities :

Collaborate and Lead Across Projects :

Stay Informed and Elevate Best Practices :

How Will You Get Here?

Education :

Experience :

Knowledge, Skills, and Competencies :