LLoyd Staffing
Executive Director Of Regulatory Affairs ( Neurology)
LLoyd Staffing, Woodcliff Lake, New Jersey, us, 07677
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 developing innovative medicines, notably the world's most widely used treatment for Alzheimer’s disease. As we 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 lead and direct global regulatory strategies for Eisai’s products under development and post-approval, ensuring effective achievement of regulatory and business objectives. The role involves overseeing the development and submission of investigational drug applications, registration dossiers, supplements, and amendments. The Director will provide strategic guidance to project teams on interactions and negotiations with regulatory agencies to expedite approvals. This includes managing GRS teams responsible for large, late-stage development programs or multiple early-stage programs. The position requires experience with NDA/BLA, MAA, and supplementary applications. Essential Functions Provide global regulatory leadership supporting development, registration, and lifecycle management of products. Ensure timely, compliant execution of regulatory strategies and programs. Manage a team of regulatory professionals developing global regulatory 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 plan meetings with FDA, EMA, PMDA, and other regulatory bodies. Participate in Health Authority inspections and respond to observations. Stay updated on regulatory environment changes and implement necessary adaptations. Provide strategic advice on policy and intelligence matters. Develop and manage staff performance and engagement. Determine timelines and budgets for regulatory activities. Lead and participate in global regulatory initiatives and committees. Qualifications 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 US and UK, with demonstrated leadership success. Proven track record in NDA/BLA, MAA, and supplementary applications. Effective interface with FDA, EMA, and other global agencies. Experience preparing marketing applications in CTD format for major markets. Strong strategic decision-making skills and operational leadership. Excellent communication, negotiation, and interpersonal skills. Ability to work collaboratively across a matrix organization. Sense of urgency and perseverance to achieve results.
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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 developing innovative medicines, notably the world's most widely used treatment for Alzheimer’s disease. As we 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 lead and direct global regulatory strategies for Eisai’s products under development and post-approval, ensuring effective achievement of regulatory and business objectives. The role involves overseeing the development and submission of investigational drug applications, registration dossiers, supplements, and amendments. The Director will provide strategic guidance to project teams on interactions and negotiations with regulatory agencies to expedite approvals. This includes managing GRS teams responsible for large, late-stage development programs or multiple early-stage programs. The position requires experience with NDA/BLA, MAA, and supplementary applications. Essential Functions Provide global regulatory leadership supporting development, registration, and lifecycle management of products. Ensure timely, compliant execution of regulatory strategies and programs. Manage a team of regulatory professionals developing global regulatory 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 plan meetings with FDA, EMA, PMDA, and other regulatory bodies. Participate in Health Authority inspections and respond to observations. Stay updated on regulatory environment changes and implement necessary adaptations. Provide strategic advice on policy and intelligence matters. Develop and manage staff performance and engagement. Determine timelines and budgets for regulatory activities. Lead and participate in global regulatory initiatives and committees. Qualifications 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 US and UK, with demonstrated leadership success. Proven track record in NDA/BLA, MAA, and supplementary applications. Effective interface with FDA, EMA, and other global agencies. Experience preparing marketing applications in CTD format for major markets. Strong strategic decision-making skills and operational leadership. Excellent communication, negotiation, and interpersonal skills. Ability to work collaboratively across a matrix organization. Sense of urgency and perseverance to achieve results.
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