Associate Director, Regulatory CMC

Vaga não está no LinkedIn

🕒 Agosto 26

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $175.000 - $200.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs under the direction of the Senior Director • Author, compile, and review CMC sections of regulatory submissions, including INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements • Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams • Support health authority interactions, including briefing documents and information request responses • Maintain regulatory compliance for CMC activities supporting clinical and commercial supply • Assist with post-approval change management, comparability assessments, manufacturing changes, and technology transfers • Manage external consultants, CMOs, CROs, and regulatory vendors

🎯 Requisitos

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline; 10+ years of progressively responsible experience in Regulatory CMC and/or technical CMC, or an equivalent combination of advanced education and experience • Technical CMC expertise gained through hands-on experience as a subject matter expert in one or more CMC disciplines, such as formulation, analytical development, process development, manufacturing, chemistry, pharmaceutical development, or quality • Ability to independently interpret complex scientific and manufacturing data and translate technical conclusions into sound regulatory strategies • Extensive hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions • Strong knowledge of FDA and global CMC regulatory requirements across development and commercial stages • Experience supporting small molecule drug products • Experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies is strongly preferred • Demonstrated leadership of complex CMC regulatory activities, including health authority interactions • Ability to influence cross-functional teams, build consensus among technical SMEs, and work effectively with external manufacturing, testing, and other development partners • Ownership mindset with a proactive, can-do attitude and strong commitment to excellence • Strong project management, organizational, written, and verbal communication skills • Ability to manage multiple programs and priorities effectively in a fast-paced, cross-functional environment • Proficiency in leveraging AI tools and other digital technologies for document preparation, review, data analysis, and day-to-day Regulatory CMC activities while maintaining scientific judgment, data integrity, confidentiality, and compliance with company policies

🏖️ Benefícios

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns