Job Description

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:

• 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.

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