Executive Director Of Regulatory Affairs ( Neurology)

Job Description Executive Director of Regulatory Affairs (Neurology) Location: Nutley, NJ (Hybrid Position) - On Site 2 Days a Week Salary Range: $270k to $350K + Bonus Lloyd Staffing is searching for an Executive Director of Regulatory Affairs. Our client is a growing pharmaceutical company specializing in neurology and oncology, with a strong focus on research and development. Our history includes the development of innovative medicines, notably the discovery of the world's most widely used treatment for Alzheimer’s disease. As we continue to expand, we seek highly motivated individuals eager to work in a fast-paced environment and make a difference. If this describes you, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and strategic direction for the global regulatory aspects of Eisai’s products under development and post-approval research. This includes developing regulatory strategies to meet business and regulatory objectives. Lead the development and submission of investigational drug applications, product registration dossiers, supplements, and amendments. Provide strategic guidance to project teams on interactions and negotiations with regulatory agencies to expedite approvals. Oversee, guide, and manage GRS teams responsible for large, late-stage development programs or multiple early-stage programs. Ensure all regulatory goals and milestones are achieved, including interactions with health authorities, using a hands-on approach. Experience with NDA/BLA, MAA, and supplementary applications is required. Essential Functions Provide global regulatory leadership for product development, registration, and lifecycle management. Ensure efficient, timely, and compliant execution of regulatory strategies. Manage a team of regulatory professionals responsible for global strategic plans for new and existing products. Serve as the lead regulatory representative throughout the product lifecycle. Advise senior staff on regulatory issues, especially in the US. Oversee and strategize meetings with FDA, EMA, PMDA, and other health agencies. Participate in health authority inspections and respond to observations. Stay updated on regulatory environment changes and implement necessary adaptations. Provide expert opinions and strategic direction on policy and intelligence matters. Engage, develop, and manage staff performance. Determine timelines and budgets for programs and report accordingly. Lead and participate in global regulatory initiatives and committees. Job Requirements Bachelor's degree with at least 12 years of industry experience, including 10+ years in Regulatory Affairs within biotech or biopharmaceutical sectors. Advanced degree in a scientific discipline preferred. Experience managing personnel in the US and UK, with demonstrated success in leading teams. Successful track record in NDA/BLA, MAA, and supplementary applications. Effective interfacing with FDA, EMA, and other global agencies. Experience preparing marketing applications in CTD format for major markets. Strong strategic decision-making skills and operational planning abilities. Excellent communication, interpersonal, and negotiation skills. Ability to work collaboratively across a matrix organization. Sense of urgency and perseverance in achieving results.

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