Senior Scientist – Global Regulatory Project Lead, Farm Animal

🔥 2 horas atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $118.000 - $197.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Elanco

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1954

🍽️ Alimentos e Bebidas

🏥 Saúde

💼 Consultoria

💰 Grant em 2017-05

Food & Beverage • Healthcare • Consulting

A Elanco é líder global em saúde animal, dedicada a inovar e a oferecer produtos e serviços para prevenir e tratar doenças em animais de produção e pets. A empresa gera valor para produtores rurais, tutores de pets, veterinários e para a sociedade ao criar soluções que respondem aos desafios da saúde animal. A Elanco investe em pesquisa e desenvolvimento (P&D) para avançar o bem-estar animal e promove práticas sustentáveis e a diversidade em suas operações no mundo todo. A empresa é conhecida por produtos como o Credelio Quattro, um parasiticida oral canino, e mantém o compromisso de ampliar o enriquecimento da alimentação e da convivência por meio de seu programa Healthy Purpose™.

Descrição

• Guide the design and development of global regulatory strategy for development projects, primarily focusing on CVM/FDA submissions • Serve as the dedicated regulatory subject matter expert on development teams • Provide risk/benefit evaluations to guide project strategy • Lead direct engagements with regulatory agencies, including pre-submission meetings and negotiations • Partner with R&D to develop and implement clinical trial submission plans • Collaborate with internal stakeholders on technical leadership for Quality, Safety, and Efficacy sections of regulatory submissions • Identify and communicate project-specific regulatory risks and opportunities to development teams and leadership • Influence cross-functional partners across R&D, Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services • Comply with company local and global policies

🎯 Requisitos

• Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field • At least 10 years of relevant experience in the animal health industry • Direct regulatory affairs experience in veterinary pharmaceuticals • Demonstrated experience leading direct submissions and negotiations with regulatory agencies • Strong preference for experience with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) • Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment • Exceptional communication, negotiation, and influencing skills • Direct regulatory experience with both farm animal and companion animal products preferred • Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously preferred • Experience navigating novel regulatory pathways for innovative products preferred • Strong understanding of risk assessment and risk management fundamentals preferred • Knowledge of Continuous Improvement methodologies, such as Six Sigma and Lean, preferred • Ability to comply with company local and global policies, including quality frameworks, Code of Conduct, anti-discrimination, harassment, and HSE policies

🏖️ Benefícios

• Multiple relocation packages • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) • 8-week parental leave • 9 Employee Resource Groups • Annual bonus offering • Flexible work arrangements • Up to 6% 401K matching • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities

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