Regulatory Device CMC Manager

🕒 Julho 14

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Syneos Health

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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

• Reviews device sections of regulatory submissions, as well as the interactions and responses with regulatory agencies • Contributes to the development of global regulatory device strategies for commercial products • Works with regulatory colleagues in development of global regulatory drug device CMC strategies and Submissions • Provides regulatory drug device CMC guidance to cross-functional teams and key stakeholders • Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

🎯 Requisitos

• Strong interpersonal skills to exchange complex information with others and to guide others • Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines • Experience in the preparation, including writing, of drug device CMC submissions • Strategic thinking and strong problem solving skills • Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner • Strong sense of planning and prioritization, and the ability to work with all levels of management • Capable of strategic thinking with ability to resolve complex and ambiguous situations • Sound knowledge of cGMP, FDA, EMA, ICH • Bachelor's degree, with a preference in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.

🏖️ Benefícios

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself.