Director, Regulatory Affairs, CMC

🕒 Outubro 21

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $190.000 - $237.000 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

👻 Score fantasma 14%

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• Aberta há 20 dias.
• As vagas desta empresa costumam ser preenchidas em 41 dias.

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Summit Therapeutics, Inc.

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51 - 200 funcionários

Fundada em 2003

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Summit Therapeutics, Inc. é uma empresa biofarmacêutica focada na oncologia, dedicada à descoberta, desenvolvimento e comercialização de terapias medicinais inovadoras com o objetivo de melhorar a qualidade de vida dos pacientes oncológicos. A empresa está particularmente comprometida em atender necessidades médicas sérias não atendidas por meio de sua principal terapia em investigação, ivonescimab, um anticorpo biespecífico inovador desenvolvido para atingir tanto PD-1 quanto VEGF. As iniciativas da Summit incluem ensaios clínicos de Fase III em andamento para avaliar a eficácia do ivonescimab no tratamento do câncer de pulmão de não pequenas células, destacando sua dedicação ao cuidado centrado no paciente e ao avanço tecnológico no campo da oncologia.

Descrição

• Develop and execute CMC regulatory strategies for clinical and commercial development and lifecycle management • Manage preparation of high-quality global Regulatory CMC submissions, including IND, IMPD, BLA, MAA, and post-approval supplements • Represent Regulatory CMC on project teams and provide strategic regulatory input • Collaborate with CMC, Supply Chain, Quality, and Regulatory Affairs teams to implement regulatory strategies • Plan and participate in Health Authority meeting requests, briefing books, and responses to information requests • Review CMC sections of regulatory submissions for compliance and strategic alignment • Lead and participate in regulatory interactions with Health Authorities • Develop Regulatory CMC strategies and risk assessments for assigned projects • Identify continuous process improvements and engage relevant teams and stakeholders • Interpret global CMC regulations and guidelines for Summit personnel • Support Health Authority inspections • Escalate regulatory compliance issues to CMC RA Management • Maintain current knowledge of global CMC regulations and guidance

🎯 Requisitos

• Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required • 10 or more years Regulatory CMC experience and/or related Pharmaceutical industry experience required • Experience in biologics required • Thorough and extensive knowledge of FDA, EU and global regulations required • Significant experience developing regulatory strategy for complex products • Experience preparing CMC sections for complex regulatory submissions • Excellent understanding of IND, CTA, BLA and MAA processes • Experience engaging with health authorities on regulatory CMC topics • Proficiency in Mandarin Chinese (spoken and written) highly desirable • Proficiency with Microsoft Office Suite, electronic document management systems, and document review tools desirable • Strong computer and database skills • Attention to detail, accuracy and confidentiality • Clear and concise oral and written communication skills • Excellent organizational skills • Critical thinking, problem solving, and ability to work independently • Ability to multitask and manage time-sensitive, highly confidential documents • Ability to communicate complex ideas clearly • Ability to prioritize conflicting demands • Ability to work in a fast-paced, demanding, and collaborative environment

🏖️ Benefícios

• Total compensation package may include bonus, stock, benefits and/or other applicable variable compensation • Equal Opportunity Employer commitment and non-discrimination in recruitment, hiring, training, and promotion

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