Senior Country Regulatory Specialist

🕒 6 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

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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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Perform country regulatory operations from study startup through project end • Provide expertise in country ethics and regulatory submissions within timelines, budgets, and quality standards • Serve as the main country-level contact with Regulatory Authorities and Ethics Committees under project leadership • Maintain regulatory country intelligence in regulatory intelligence systems • Interact with customers regarding Regulatory Authority and local regulatory requirements • Consult on pre-award regulatory submission strategy • Provide country-level regulatory expertise for business development presentations and site selection • Forecast submission and approval timelines, track milestones, analyze delays, propose mitigation plans, and escalate risks • Prepare and submit Central Ethics Committee, Local Ethics Committee, Regulatory Authority, hospital, amendment, notification, and safety submissions • Interact with Regulatory Authorities and Ethics Committees and coordinate query responses • Serve as country-level regulatory SME throughout assigned projects • Ensure relevant documents are submitted to the Trial Master File • Complete or contribute to Regulatory Impact Assessments and implement operational actions as regulations change • Develop or support local country regulation training materials • Train and mentor junior Country Regulatory Specialists • Support Procurement in managing Ethics/IRB vendors when required • Provide input to SOPs and Work Instructions and drive continuous quality improvement • Review SOPs and Work Instructions, maintain training compliance, and report timesheets accurately • Monitor workload, scope, budgeted effort, and project hours; escalate discrepancies

🎯 Requisitos

• Minimum of a BA or BS preferred • 5-6 years minimum experience working in a Clinical Research environment, or an equivalent combination of education and experience • Detailed understanding of clinical trial process across Phases I-IV and ICH GCP • Detailed understanding of clinical trial submission processes per-country and local regulations • Experience working to applicable GxPs (e.g. GVP, GCP, ISO 14155) • Strong organizational and problem-solving skills • Strong presentation, documentation, influencing, and communication skills • Team-oriented approach • Knowledge and interpersonal skills necessary to train and mentor junior Country Regulatory Specialists • Proficient computer skills in Microsoft Office Suite, web-based systems, voicemail, Email and Internet • Ability to manage competing priorities in a dynamic fast-paced environment • Ability to work independently and as part of a team

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate