Associate Director of Regulatory Affairs, CMC

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🕒 Setembro 24

🏄 California – Remoto

🏄 California – Remote

💵 $185.000 - $200.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Artiva Biotherapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

💰 Series B em 2021-02

Biotechnology • Healthcare • Pharmaceuticals

A Artiva Biotherapeutics é uma empresa de imunoterapia com capacidade de produzir terapias celulares NK alogênicas prontas para uso em larga escala. Nossa missão é desenvolver terapias celulares eficazes, seguras e acessíveis para pacientes com doenças autoimunes devastadoras e cânceres. Nosso principal programa, o AlloNK®, é um candidato a terapia celular NK alogênica, não modificado geneticamente, projetado para melhorar a atividade de anticorpos monoclonais ou ativadores de células NK. O AlloNK está atualmente em ensaios clínicos em combinação com rituximabe para o tratamento de lúpus eritematoso sistêmico (LES) em pacientes com nefrite lúpica ativa e para o tratamento de Linfoma Não-Hodgkin, bem como em combinação com o ativador de células inatas AFM13 da Affimed para o tratamento de pacientes com linfomas CD30-positivos recidivantes/refratários.

Descrição

• Serve as primary author and lead reviewer for CMC sections of late-stage and commercial regulatory filings, including BLAs, MAAs, IMPDs, INDs, amendments, and supplements • Author scientifically rigorous Module 3/CTD dossier content covering drug substance, drug product, and analytical sections • Support commercial lifecycle management, including post-approval submissions, comparability protocols, CMC supplements, labeling updates, and annual product reviews • Contribute to ex-US submissions, particularly EMA and ANVISA filings • Prepare and coordinate FDA, EMA, and other health authority meeting packages, briefing documents, slide decks, and written responses • Provide CMC regulatory input on process characterization, comparability studies, analytical method validation, and stability programs • Compile, organize, and author regulatory documents and responses to health authority queries and deficiency letters • Maintain knowledge of global CMC regulations and cell and gene therapy guidance • Contribute to regulatory intelligence and best-practice initiatives • Track regulatory commitments, submission timelines, annual reporting, and post-approval reporting obligations • Work cross-functionally with Quality, Process Development, Manufacturing, Analytical Development, Clinical, and CMC leadership teams • Provide informal mentorship and contribute to junior regulatory staff development

🎯 Requisitos

• Bachelor’s degree required in life sciences, chemistry, biochemistry, or a related field • 7 years of regulatory CMC experience in the biopharmaceutical industry • Minimum of 3-5 years of direct, hands-on experience in cell therapy (allogeneic and/or autologous) • Late-stage and/or commercial CMC regulatory experience • Demonstrated experience with BLA and/or MAA submissions strongly preferred • Strong, independent authorship of CMC regulatory submissions, including Module 3/CTD • Hands-on experience with lifecycle management CMC activities, including post-approval supplements, comparability protocols, commercial manufacturing changes, and annual reports • Working knowledge of late-stage and commercial CMC operations and development activities, including process characterization and validation, analytical method validation, stability study design, and scale-up/tech transfer • Experience with ex-US regulatory submissions, specifically EMA and ANVISA • Experience supporting formal health authority meeting requests and interactions with FDA, EMA, and/or ANVISA • Strong knowledge of global CMC regulations and guidelines applicable to biologics and cell/gene therapy, including FDA regulations (21 CFR), EMA guidelines, ICH Q5-Q12 series, and other ex-US requirements • Excellent written communication skills and ability to independently author, review, and edit regulatory documents • Strong organizational skills and attention to detail; ability to manage multiple priorities and deadlines • Ability to collaborate cross-functionally with Quality, Process Development, Manufacturing, Clinical, and CMC leadership teams • Ability to provide informal mentorship and contribute to development of junior regulatory staff • San Diego, CA preferred; highly qualified remote candidates considered

🏖️ Benefícios

• A beautiful facility • An entrepreneurial, highly collaborative, and innovative environment • Medical, Dental, and Vision • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Paid Time Off (PTO) • Company paid holidays, including the year-end holiday week • Bonus.ly recognition program where points can be traded for desired items