Senior Manager Regulatory Affairs (Aliso Viejo)Groe Advisors • Aliso Viejo, CA, United States
Senior Manager Regulatory Affairs (Aliso Viejo)
Groe Advisors • Aliso Viejo, CA, United States
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job_description.job_card.job_descriptionOversee 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. 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. Ensure regulatory deliverables are aligned with project timelines and milestones. Champion effective cross-functional coordination and regulatory best practices across departments. 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. Bachelors degree in a scientific discipline required. Advanced degree (MS, PharmD, PhD) strongly preferred. 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. Regulatory Affairs Certification (RAC) is beneficial.
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, were 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 :
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Senior Manager Regulatory • Aliso Viejo, CA, United States
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