Senior Director, Regulatory CMC

🕒 Setembro 10

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $203.000 - $253.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 11%

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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Summit Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2003

🏥 Saúde

💼 Consultoria

📣 Marketing

🔥 Investimento no último ano

💰 $500.000.000 Post-IPO Equity - Summit Therapeutics em 2025-10

Healthcare • Consulting • Marketing

A Summit Therapeutics, Inc. é uma empresa biofarmacêutica especializada em oncologia, focada na descoberta, desenvolvimento e comercialização de novas terapias medicinais para melhorar a qualidade e a duração de vida de pacientes com necessidades médicas não atendidas. A empresa está avançando com o ivonescimab (SMT112), um novo anticorpo biespecífico que tem como alvo PD-1 e VEGF, através de múltiplos ensaios clínicos de Fase 3 para o câncer de pulmão de não pequenas células e outros tumores sólidos sob licença da Akeso. A Summit enfatiza o desenvolvimento clínico, estratégias de registro regulatório e potencial comercialização em seus territórios licenciados enquanto promove opções de tratamento que beneficiam tanto pacientes quanto cuidadores.

Descrição

• Provide strategic leadership and oversight for global CMC regulatory activities across assigned programs and the broader portfolio • Define and execute global CMC regulatory strategy to support clinical development, licensure, and lifecycle management of biologic products • Represent Regulatory CMC at senior project team and governance levels • Lead cross-functional collaboration with CMC, Supply Chain, Quality, and Regulatory Affairs to develop and align global regulatory strategies and submission plans • Oversee planning, development, and finalization of high-quality CMC regulatory documents • Provide executive oversight of internal CMC submission review and approval processes • Lead regulatory CMC activities related to Health Authority interactions, including meeting strategy, briefing document oversight, and responses to information requests • Assess regulatory impact of CMC changes, deviations, and lifecycle management activities; direct associated regulatory submissions • Oversee timelines, resource planning, and prioritization of regulatory CMC activities • Serve as a subject matter expert on global CMC regulations and guidance • Lead continuous improvement initiatives for Regulatory CMC processes, systems, and cross-functional effectiveness • Escalate significant regulatory risks or compliance issues to senior leadership with recommendations for resolution • Monitor global CMC regulatory trends, emerging guidance, and Health Authority expectations • Mentor, develop, and provide leadership to Regulatory CMC staff

🎯 Requisitos

• Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biochemistry, or related scientific discipline required; advanced degree (Master’s or PhD) strongly preferred • 10 or more years of Regulatory CMC experience and/or related pharmaceutical/biotechnology industry experience required, with demonstrated leadership responsibility • Significant experience with biologic products across clinical development and commercialization required • Deep and comprehensive knowledge of FDA, EU, and other global CMC regulatory requirements and expectations • Extensive experience leading preparation and review of CMC sections for global regulatory submissions (IND, IMPD/CTA, BLA, MAA, variations, supplements, amendments) • Strong understanding of global development and registration processes including IND, CTA, BLA, and MAA pathways • Prior experience serving as a regulatory CMC lead in Health Authority interactions • Proficiency in Mandarin Chinese (spoken and written) is highly desirable • Proficient with Microsoft Office applications (Word, Excel) and experienced with electronic document management and regulatory publishing systems • Strong analytical, problem-solving, and strategic thinking skills • Excellent written and verbal communication skills • Demonstrated ability to lead, influence, and collaborate across functions at both operational and senior leadership levels • Exceptional organizational skills with the ability to manage multiple, time-sensitive priorities • Proven ability to work effectively in a fast-paced, demanding, and highly collaborative environment while maintaining attention to detail, confidentiality, and regulatory compliance

🏖️ Benefícios

• Bonus, stock, benefits and/or other applicable variable compensation may be included in the total compensation package • Equal Opportunity Employer