Director of Regulatory Affairs

Sr. Manager / Director, Regulatory Affairs. Relocation required to Southern CA. Role Overview We are seeking an experienced regulatory affairs leader to drive strategy, oversee submissions, and guide interactions with global health authorities. This individual will play a pivotal role in ensuring regulatory success for our combination products and pharmaceutical programs while mentoring a growing team. Key Responsibilities Lead Regulatory Strategy & Execution Define and deliver comprehensive global regulatory strategies supporting product development and lifecycle goals. Serve as the primary regulatory voice on cross-functional project teams, influencing development plans, labeling, and compliance initiatives. Review, approve, and ensure accuracy of documentation supporting product submissions and approvals. Provide leadership and mentorship to regulatory team members, fostering professional growth and regulatory excellence. Regulatory Submissions Direct the planning, authoring, and coordination of global submissions, including INDs, NDAs, CTAs, and annual reports. Partner with subject matter experts to ensure submissions meet technical, scientific, and regulatory standards. Troubleshoot and resolve challenges that arise during submission preparation and review. Health Authority Engagement Lead communications and meetings with the FDA, EMA, and other regulatory bodies globally. Prepare briefing packages, coordinate Q&A responses, and manage submission-related interactions. Cross-Functional Collaboration Align regulatory deliverables with broader program timelines and corporate milestones. Partner closely with R&D, Quality, Clinical, and Commercial teams to enable a unified approach to development and compliance. Regulatory Intelligence & Process Improvement Stay current with evolving FDA, ICH, and EU regulations impacting combination products and pharmaceuticals. Recommend and implement process enhancements to improve submission efficiency and regulatory compliance. Share best practices and emerging trends across the organization. Qualifications Education Bachelor’s degree in a scientific or technical discipline required. Advanced degree preferred. Experience Minimum 7 years of industry experience, with at least 4 years in Regulatory Affairs focusing on pharmaceuticals and/or combination products. Demonstrated success in preparing and leading global regulatory submissions (INDs, NDAs, CTAs) and managing regulatory authority interactions. Previous leadership experience with direct reports or cross-functional teams strongly desired. Other In-depth knowledge of 21 CFR, FDA/ICH guidance, GxPs, and EU regulatory frameworks. Excellent communication, collaboration, and presentation skills. Strong project management and problem-solving abilities. Senioritiy level Director Employment type Full-time Job function Quality Assurance, Project Management, and Science Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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