Director – US RA CMC Team Leader, Global CMC Regulatory Affairs

🕒 6 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $180.000 - $230.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Dechra

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1997

💊 Farmacêutico

🏥 Saúde

💰 IPO em 2000-08

Pharmaceuticals • Healthcare

A Dechra é uma empresa internacional de produtos farmacêuticos veterinários e produtos relacionados. A empresa desenvolve, fornece e oferece suporte a medicamentos de alta qualidade e produtos complementares exclusivamente para veterinários e profissionais da área em todo o mundo. A Dechra valoriza serviços especializados para a área veterinária, oferecendo suporte clínico, educação profissional por meio da Dechra Academy e iniciativas globais de distribuição e sustentabilidade. Assim, posiciona-se como parceira dos profissionais veterinários para promover a saúde e o bem-estar dos animais.

Descrição

• Lead the US Regulatory Affairs CMC team, setting priorities and supporting delivery of high-quality regulatory strategies and submissions • Provide strategic US CMC regulatory leadership across development and lifecycle activities • Oversee preparation, review, and submission of CMC sections for US regulatory applications, amendments, supplements, and responses to health authority questions • Partner with Global CMC Regulatory Affairs colleagues and cross-functional teams, including technical development, manufacturing, quality, and supply • Advise project teams on US regulatory requirements, risks, and opportunities • Build and advance innovation in CMC regulatory processes, tools, and ways of working • Represent the organisation in interactions with US health authorities • Monitor changes in US CMC regulations and guidance and communicate relevant developments • Develop team capabilities through coaching, feedback, and knowledge sharing • Support approved veterinary products, CMC compliance, lifecycle management, post-approval strategy, technology transfers, site strategy, manufacturing changes, product and process improvements, and global innovation strategies for pipeline programs

🎯 Requisitos

• Extensive experience in CMC Regulatory Affairs, including substantial experience supporting US regulatory submissions and product lifecycle activities • Strong knowledge of US CMC regulations, guidance and health authority expectations • Experience leading, developing or mentoring regulatory professionals and coordinating complex, cross-functional work • Demonstrated ability to shape regulatory strategy and provide clear, risk-based advice on complex CMC matters • Experience managing submission planning, content review and responses to health authority questions • Interest in driving innovation and continuous improvement in regulatory processes and operations • Excellent written and verbal communication skills, with the ability to influence and collaborate across teams and levels of an organisation • Strong organisational skills and the ability to manage multiple priorities in a changing environment • Relevant scientific degree; BS/MS/Ph.D. in Science such as Biology, Biochemistry, Chemistry, or Bioengineering • Significant industry experience in CMC regulatory affairs and in CMC regulatory affairs innovation/product development • Regulatory exposure in global regions is required

🏖️ Benefícios

• Competitive salary

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