Distinguished Scientist, Regulatory Liaison

🔥 21 horas atrás

🏖️ New Jersey, Maryland – Remoto

🏖️ New Jersey – Remote 🦀 Maryland – Remote

💵 $231.900 - $365.000 / ano

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🚔 Conformidade

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MSD

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1891

🏥 Saúde

📦 Logística

🧬 Biotecnologia

Healthcare • Logistics • Biotechnology

A MSD é uma empresa biofarmacêutica líder, conhecida como Merck & Co. , Inc. nos Estados Unidos, no Canadá e em Porto Rico, e como MSD globalmente. A companhia tem foco em inovação científica para oferecer medicamentos e vacinas para diversos desafios de saúde, incluindo oncologia, vacinas, doenças infecciosas e doenças cardiometabólicas. A MSD opera múltiplas divisões, incluindo Saúde Humana, Saúde Animal e Pesquisa e Desenvolvimento (P&D). Com aproximadamente 75 mil colaboradores no mundo e investimentos significativos em pesquisa e desenvolvimento, a MSD está comprometida em melhorar a saúde global por meio de seus avanços científicos. Além disso, a empresa dá grande ênfase à diversidade, à inclusão e à responsabilidade corporativa. As operações da MSD se estendem mundialmente, oferecendo oportunidades em diversas regiões e promovendo diversidade e inovação em todos os aspectos de seus negócios.

Descrição

• Develop and oversee global regulatory strategies for companion diagnostics and other in vitro diagnostic products • Provide strategic and tactical CDx/IVD regulatory guidance to product development teams, regulatory liaisons, and senior leaders • Manage regulatory activities related to development, registration, approval, and lifecycle management of companion diagnostics and other IVD products • Provide regulatory leadership for complex programs or major components of high-priority programs • Assess the impact of diagnostic and drug regulations on diagnostic development, clinical development, and global registration strategies • Review regulatory strategies and ensure plans are scientifically sound, compliant, and aligned with development objectives • Identify regulatory risks and develop pragmatic approaches supporting compliance, objectives, and timelines • Collaborate across organizational and geographic boundaries to resolve regulatory issues • Manage senior stakeholders and communicate program risks, regulatory issues, and mitigation strategies • Lead regulatory interactions with external diagnostic partners • Oversee or contribute to diagnostic regulatory submissions, including IDEs, PMAs, 510(k)s, pre-submission materials, and other filings • Lead or support interactions with regulatory authorities, including briefing documents, meeting strategies, and agency meetings • Review and approve regulatory communications, background packages, and submission materials • Review labeling and manage labeling negotiations with regulatory authorities • Support global development and registration activities with international colleagues and diagnostic partners • Participate in regulatory due diligence involving partners, development agreements, licensing opportunities, and external products or technologies • Support external scientific and regulatory engagement, policy, and advocacy activities • Monitor regulatory developments and represent the company in external initiatives and regulatory-authority interactions • Lead and manage a team of regulatory professionals • Assign regulatory liaisons, manage resources and priorities, recruit and onboard staff, and provide coaching, mentoring, performance management, development planning, and career guidance • Establish expectations and promote consistent regulatory practices • Foster an inclusive, collaborative environment promoting scientific rigor, accountability, and cross-functional partnership

🎯 Requisitos

• Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or a related discipline, with a minimum of 12 years of relevant drug-development or regulatory experience, including substantial experience in regulatory affairs; or master’s degree with a minimum of 10 years of relevant experience; or doctoral degree with a minimum of 7 years of relevant experience • Significant regulatory experience in companion diagnostics and/or in vitro diagnostics • Demonstrated knowledge of diagnostic product development and regulatory requirements applicable to companion diagnostics and IVDs • Experience developing regulatory strategies and supporting regulatory submissions for diagnostic products • Experience interacting with the U.S. Food and Drug Administration or other regulatory authorities • Strong scientific knowledge, professional credibility, and familiarity with regulatory requirements across relevant global markets • Ability to interpret evolving regulatory requirements and apply them to complex development programs • Ability to develop creative and pragmatic regulatory strategies for complex or unprecedented issues • Experience leading high-performing teams or projects and managing multiple priorities in a matrixed environment • Ability to communicate complex scientific and regulatory issues clearly and effectively to senior leaders, development teams, diagnostic partners, and regulatory authorities • Outstanding written, verbal, interpersonal, negotiation, and presentation skills • Strong organizational skills, sound judgment, and ability to work independently while maintaining effective collaboration across functions • Demonstrated leadership attributes, including relationship building, influencing decisions, constructive conflict management, and developing regulatory professionals • No visa sponsorship

🏖️ Benefícios

• Annual bonus and long-term incentive, if applicable • Medical, dental, vision healthcare and other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement

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