Senior Director, Regulatory Affairs CMC

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🕒 Setembro 14

🏖️ New Jersey, Maryland, +3 estados a mais – Remoto

🏖️ New Jersey – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🔔 Pennsylvania – Remote ⚔️ Virginia – Remote

💵 $249.995 - $272.020 / ano

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Miltenyi Biotec

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

🏥 Saúde

💼 Consultoria

🏭 Manufatura

Healthcare • Consulting • Manufacturing

A Miltenyi Biotec é uma empresa global de biotecnologia que desenvolve e fabrica instrumentos, reagentes e softwares para separação celular, citometria de fluxo, análise de célula única e pesquisa e fabricação de terapia celular e gênica. Seus produtos e serviços apoiam a pesquisa acadêmica, estudos translacionais e processos de fabricação clínica, permitindo isolamento, análise e manipulação de células para imunologia, neurociência, pesquisa em câncer e medicina regenerativa.

Descrição

• Lead the team of global CMC Regulatory Affairs managers • Serve as the global regulatory expert for Chemistry, Manufacturing & Controls activities supporting the Cell & Gene Therapy portfolio • Provide strategic regulatory leadership across development, registration and lifecycle management • Coach, mentor and lead global CMC Regulatory Affairs managers • Lead global CMC regulatory strategies for Cell & Gene Therapy products throughout development and commercialization • Oversee, develop strategy for, review and approve CMC sections for regulatory submissions, including INDs, CTAs, BLAs, MAAs, amendments and post-approval variations • Provide strategic guidance on regulatory requirements related to manufacturing processes, analytical methods, specifications, comparability studies, process validation and control strategies • Assess regulatory impact of manufacturing changes and define appropriate regulatory pathways worldwide • Support interactions with global health authorities including FDA, EMA, MHRA and other agencies • Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions • Monitor regulatory developments and industry trends relevant to advanced therapies and translate them into regulatory strategies • Drive regulatory risk assessments and mitigation plans across the product lifecycle • Perform duties in an office environment and meet specified physical demands

🎯 Requisitos

• Master's degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline • +12 years demonstrated hands-on expertise in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for Cell & Gene Therapy (CGT) products is mandatory • Extensive experience in Regulatory Affairs within biotechnology and/or pharmaceutical environments • Proven experience supporting global regulatory submissions and interactions with health authorities, particularly in Europe and the US • Deep understanding of biologics, ATMPs, Cell & Gene Therapy products and global regulatory frameworks • Excellent communication, leadership and project management skills • Fluent English written and verbal communication skills • Substantial regulatory affairs strategy and submissions experience in one or more of: cell therapies, gene therapies, viral vectors, Advanced Therapy Medicinal Products (ATMPs), biological product development and manufacturing • Ability to handle more than one task at a time • Ability to perform the stated physical duties, including occasionally lifting or moving up to 25 pounds

🏖️ Benefícios

• Health insurance • Vision insurance • Dental insurance • 401(k) plan • Additional compensation such as bonuses or commissions may be available for certain positions • Reasonable accommodations for candidates and employees with disabilities