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Senior Manager Regulatory Affairs

Senior Manager Regulatory Affairs

Groe Advisors LLCAliso Viejo, CA, United States
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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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    Manager Regulatory • Aliso Viejo, CA, United States

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