Senior Manager, Global Regulatory Affairs

🕒 Junho 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $150.034 - $224.250 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 28%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• Support development of global regulatory strategy, planning, and execution for investigational and marketed prescription drug submissions • Manage lifecycle regulatory activities for assigned projects in alignment with the Global Regulatory Lead • Obtain regulatory intelligence and research precedent approvals and health authority decisions • Translate global requirements and assess regulatory challenges for regulatory and project teams • Collaborate with global regulatory team members to develop regulatory plans and address regulatory issues, health authority queries, and obligations • Author, coordinate, review, and execute submissions and responses to regulatory authorities • Independently manage preparation of INDs, CTAs, amendments, supplements, and aggregate reports • Confirm submission documents are accurate, compliant, and high-quality • Serve as sponsor point of contact to health authorities • Represent Global Regulatory Affairs in project team meetings and provide regulatory guidance • Manage and direct internal support staff and external consultants • Gather data and develop documentation for on-time submissions • Execute departmental initiatives to improve efficiency, quality, and output • Assess and develop innovative ideas to address current and future departmental challenges

🎯 Requisitos

• Experience working in the pharmaceutical and/or healthcare industry • Knowledge and experience preparing global regulatory submissions, including IND, CTA, NDA or BLA, and MAA • Bachelor's degree with 5+ years’ experience OR Master’s degree with 2 years’ experience in regulatory affairs or related areas • Experience in regulatory affairs or related areas such as clinical development, project management, or quality assurance • Experience with FDA or other health authority interactions desirable • Strong oral and written communication skills • Working knowledge of the drug development process, laws, regulations, and guidelines, including FDA and ICH • Ability to interpret and apply regulatory intelligence • Ability to lead teams, prioritize work, proactively manage and communicate issues, and track project progress and risks • Ability to establish working relationships with cross-functional teams • Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills • Strong experience with Microsoft Office programs: Word, Excel, PowerPoint, and Outlook • Familiarity with electronic document management systems (EDMS) • RAC certification a plus • Approximately 20% travel

🏖️ Benefícios

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death & dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Incentive opportunity