Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls

🕒 Outubro 12

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $106.400 - $159.600 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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👻 Score fantasma 14%

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• Aberta há 29 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.
• Repostada uma vez.

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GE HealthCare

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1892

🏥 Saúde

💊 Farmacêutico

Healthcare • Medical Technology • Pharmaceuticals

A GE HealthCare é líder em cuidado de precisão, dedicada a oferecer tecnologias inovadoras e soluções integradas que elevam a qualidade dos serviços de saúde. Como empresa independente, tem foco em diagnóstico por imagem, ultrassom e TI em saúde, capacitando profissionais de saúde e melhorando os desfechos dos pacientes por meio de tecnologias médicas avançadas e soluções de cuidado personalizado. Com investimento significativo em pesquisa e desenvolvimento (P&D), a GE HealthCare busca transformar a área da saúde, tornando os hospitais mais eficientes e as terapias mais precisas.

Descrição

• Provide CMC-related strategic regulatory input for assigned projects and products • Build or contribute to submission strategy documents by defining variation type, supporting data, and required submission documents • Review and approve published output • Guide project teams with the Global Regulatory Lead during project planning to ensure appropriate data and detail are collected and submitted for all markets • Review, write, and edit CMC submission documents and dossier sections • Maintain registration tracking information • Assist in developing good document management practice standards • Collaborate with global and regional regulatory affairs teams to address regulatory authority questions • Provide proactive CMC regulatory advice and assess impact on product dossiers for key brand CMC variations • Advise project teams • Support Quality Assurance during audits and inspections • Keep current with CMC-related guidelines

🎯 Requisitos

• Bachelor's Degree and 6+ years of experience • Experience in a diagnostic, pharmaceutical, or medical device industry • Ability to prioritize, plan & evaluate deliverables to established strategic goals • Demonstrated experience operating in a highly regulated environment • Analytical skills in a CMC regulatory environment • Knowledge and experience in a scientifically related field, e.g. pharmaceutical sciences, chemistry, and analytical sciences • Experience in electronic document management and Quality management systems • Knowledge of international CMC regulatory requirements • Experience in pharmaceutical CMC regulatory or QA environment, particularly injectable diagnostic or pharmaceutical products • Experience working within a matrix organization • Experience with Veeva RIM or other registration tracking tools • Strong interpersonal, influencing, problem-solving, and negotiation skills • Must be legally authorized to work in the United States • Successful completion of a drug screen, as applicable • Master's Degree is a desired characteristic

🏖️ Benefícios

• Medical, dental, and vision insurance • Paid time off • 401(k) plan with employee and company contribution opportunities • Life, disability, and accident insurance • Tuition reimbursement • Professional development • Challenging careers • Competitive compensation • Performance-based incentive compensation, which may include cash bonus(es) and/or long-term incentives (LTI)

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