Senior Regulatory CMC Consultant - Small Molecule, Veeva RIM

Vaga não está no LinkedIn

🕒 Julho 31

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

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

• Support the execution of global regulatory CMC strategies for marketed and development products • Contributes to the preparation and submission of regulatory CMC documentation for a small molecule • Provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs • Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies • Contributes to the development of global regulatory CMC strategies for commercial products • Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions • Provides regulatory 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, LATAM, Middle East, and ICH) guidelines • Experience in the preparation, including writing, of 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 • Committed to building an inclusive culture