Director, RA, OSD/API

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🕒 Julho 25

🌐 Estados Unidos, Canadá – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇨🇦 Canadá – Remoto

🏈 Ohio – Remoto

🏈 Ohio – Remote

💵 $150.000 - $218.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Lead strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions • Develop and implement regulatory strategies • Mentor teams and manage relationships with regulatory agencies worldwide • Oversee regulatory compliance activities and provide expert guidance • Ensure successful product submissions across various jurisdictions • Collaborate with cross-functional teams to shape regulatory strategy for product development, manufacturing, and commercialization • Influence global regulatory policy and drive innovation in regulatory approaches

🎯 Requisitos

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical/medical device regulatory affairs with emphasis on manufacturing operations • Preferred Fields of Study: Life Sciences, Pharmacy, Chemistry, Microbiology, or related field • Comprehensive knowledge of global regulatory requirements, particularly FDA, EMA, and ICH guidelines • Successful track record of regulatory submissions and agency interactions • Leadership experience managing and mentoring multi-site teams • Experience in regulatory strategy development and implementation • Demonstrated expertise in regulatory compliance and quality management systems • Advanced project management and organizational skills • Excellent verbal and written communication abilities • Effective negotiation and influencing skills • Ability to work effectively in a matrix organization • Business acumen and strategic thinking capabilities • Proficiency in standard office technology and regulatory systems • Fluency in English required; additional language skills advantageous • Ability to travel 25-50% of time, primarily international • Experience with CDMO/pharmaceutical services preferred • Knowledge of current industry trends and participation in professional associations (e.g., TOPRA, PDA)

🏖️ Benefícios

• Accessibility/Disability Access • Professional development opportunities