Senior Manager, Regulatory Affairs

🕒 2 dias atrás

🏄 California – Remoto

🏄 California – Remote

💵 $170.000 - $195.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 12%

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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Braveheart Bio

SiteLinkedInTodas as Vagas

1 - 10 funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A Braveheart Bio é uma empresa de biotecnologia em estágio clínico, focada em transformar o tratamento da cardiomiopatia hipertrófica (CMH) e de condições relacionadas. A empresa está desenvolvendo terapias investigacionais que têm como alvo seletivo a miosina hiperativa — um mecanismo fundamental da doença na CMH — e avançando um programa em desenvolvimento clínico global de estágio avançado (Fase 3), com o objetivo de melhorar o desempenho cardíaco e a qualidade de vida dos pacientes.

Descrição

• Manage preparation and coordination of U.S. IND submissions • Ensure IND submissions contain required documents and meet FDA requirements • Provide regulatory guidance on U.S. IND processes, FDA meeting requests, and briefing packages • Manage FDA information requests and sponsor responses • Support FDA regulatory interactions and IND maintenance activities, including protocol amendments, information amendments, CMC changes, safety reports, annual reports, and notifications • Support NDA submissions, including coordination of module content and pre-NDA meeting packages • Track U.S. submission status and maintain inspection-ready documentation and regulatory archives • Manage preparation, compilation, and submission of ex-U.S. CTAs, including EU CTIS and country-specific applications • Ensure CTA packages meet regional and country-specific requirements • Provide guidance on EU CTIS and country-specific CTA processes • Manage health authority questions and sponsor responses • Support CTA maintenance activities, including substantial modifications, IMPD updates, quality changes, annual updates, and notifications • Support preparation of MAAs and other ex-U.S. marketing applications • Track ex-U.S. submission status and maintain inspection-ready documentation and regulatory archives • Contribute to global regulatory strategy, health authority engagement plans, and submission timelines • Monitor evolving U.S., EU, and ex-U.S. regulatory requirements and assess their impact on development plans • Oversee regulatory vendors to ensure quality and on-time delivery • Serve as regulatory liaison across internal teams and external partners • Partner with Clinical Development and Clinical Operations on global study start-up timelines • Collaborate with CMC and Quality teams on IND, IMPD, and quality documentation • Report to the Vice President of Regulatory Affairs

🎯 Requisitos

• Bachelor’s degree • Minimum of 7 years of regulatory affairs experience in biotech or pharmaceutical drug development, with a strong focus on U.S., EU, and ex-U.S. clinical trial submissions • Demonstrated hands-on experience with U.S. IND submissions, EU CTA submissions in CTIS, ex-U.S. CTA preparation and coordination, and health authority interactions and response management • Strong knowledge of U.S. FDA regulations, including 21 CFR Parts 312 and 314 • Strong knowledge of EU regulatory frameworks, including EU CTR 536/2014, EMA guidance and CTA requirements, and applicable ICH guidelines • Experience managing IND and CTA lifecycle activities, including amendments, updates, and maintenance • Strong project management and organizational skills • Ability to work independently, manage multiple priorities, and meet deadlines in a lean, fast-paced environment • Demonstrated ability to write clear, accurate regulatory documents • Detail-oriented with a commitment to quality and compliance • Strong written and verbal communication skills with a collaborative, team-oriented approach • Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity • Flexible, proactive, and hands-on mindset • Advanced degree (MS, PhD, PharmD) preferred • Preferred experience with regulatory submissions in the UK, Canada, Australia, South Korea, or LATAM • Preferred experience supporting NDAs and MAAs • Preferred experience in cardiovascular, rare disease, or small molecule drug development • Familiarity with ex-U.S. CMC regulatory requirements preferred • Experience with Veeva RIM or similar document management systems preferred • Employment authorization verified through the federal E-Verify program

🏖️ Benefícios

• Competitive total rewards package • Annual bonus eligibility • Equity eligibility • Comprehensive benefits offering