Senior Manager – Regulatory Affairs

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $160.000 - $225.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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BridgeBio

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2015

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

A BridgeBio é uma empresa de biotecnologia focada em projetar medicamentos transformadores para pacientes com doenças genéticas. Ela emprega uma abordagem inovadora para o desenvolvimento de medicamentos, integrando finanças à ciência para oferecer soluções da forma mais eficiente possível. A empresa está comprometida em desenvolver não só medicamentos que mudam vidas, mas também líderes na área, incentivando o envolvimento prático e a busca por inovação. A BridgeBio busca ativamente investimentos para ajudar a alcançar sua missão de fornecer soluções para populações de pacientes únicas com necessidades não atendidas. Com sede em Palo Alto, CA, a BridgeBio enfatiza a conexão entre avanços científicos e cuidados com o paciente.

Descrição

• Develop and execute regional regulatory strategies for development programs • Provide regional regulatory guidance and strategic oversight for product development and registration, including nonclinical and clinical development • Plan, compile, review, and submit regulatory documents, including initial INDs, CTAs, NDAs, amendments, and supplements • Represent Regulatory Affairs at cross-functional team meetings • Lead study-related regulatory activities and serve as the regulatory study representative • Provide strategic regulatory guidance for study-level decision-making • Keep study teams informed of regulatory activities • Own study-level global regulatory activities, including CTA and IND submissions, investigator document package reviews, FDA submissions, and other study regulatory activities • Track regulatory and ethics submissions and approvals across studies • Facilitate FDA and other health authority meetings with Regulatory leadership • Collaborate with project teams on planning, review, finalization, and sign-off of regulatory submissions • Develop, maintain, and communicate regulatory submission timelines • Review protocols, ICFs, IBs, CSRs, and DSURs for regulatory compliance before submission • Coordinate with CROs and vendors to plan and finalize health authority submissions • Manage regulatory agency queries and commitments, coordinate written responses, and provide status updates • Contribute to global regulatory submissions and strategic planning • Maintain regulatory databases, submission logs, and correspondence logs • Review, write, and present regulatory guidelines and SOPs • Maintain current knowledge of US and global regulations, guidance, and standards for drug development and product registration

🎯 Requisitos

• BA/BS degree in the biological or physical sciences; advanced degree (e.g., PharmD or PhD) preferred • Relevant pharmaceutical industry experience, including regulatory affairs experience • Minimum of 3 years of industry experience generally required for the Senior Manager level; greater experience and scope expected at the Associate Director level • An equivalent combination of education and experience may be considered • Knowledge of US FDA and international pharmaceutical guidance and regulations, including 21 CFR, ICH, GCP, GMP, and EMA • Knowledge of the drug development process and industry-standard practices • Demonstrated experience supporting eCTD-formatted submissions, including INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements • Experience coordinating or supporting responses to health authorities or other critical submission projects while maintaining agreed timelines • Proficient written, oral, and interpersonal communication in English • Ability to collaborate with regulatory colleagues and the broader development organization • Capability to provide strategic guidance on regulatory and program-related issues • Ability to problem solve unexpected problems or roadblocks • High attention to detail; ability to organize, prioritize, and delegate assigned projects • Experience interacting with CROs in management of US eCTD IND submissions and ex-US CTAs toward clinical trial activations preferred • Proficient user of Microsoft Office, including Word, Excel, and PowerPoint • Experience using Veeva electronic document management systems and document review tools

🏖️ Benefícios

• Market-leading compensation • Annual performance bonus • Company equity • 401(k) with employer match • Employee Stock Purchase Program (ESPP) • Pre-tax commuter benefits (transit and parking) • Referral bonus for hired candidates • Subsidized lunch and parking on in-office days • 100% employer-paid medical, dental, and vision premiums for you and your dependents • Health Savings Account (HSA) with annual employer contributions • Flexible Spending Accounts (FSA) • Fertility & family-forming benefits • Expanded mental health support (therapy and coaching resources) • Hybrid work model with flexibility • Flexible, “take-what-you-need” paid time off and company-paid holidays • Comprehensive paid medical and parental leave • Skill development and internal mobility opportunities • Continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching • Financial rewards, peer-to-peer recognition, and growth opportunities

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