Senior Scientist – Global Regulatory Project Lead, Farm Animal

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $118k - $197k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Elanco

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1954

🍽️ Food & Beverage

🏥 Healthcare

💼 Consulting

💰 Grant on 2017-05

Food & Beverage • Healthcare • Consulting

Elanco is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets. The company creates value for farmers, pet owners, veterinarians, and society by producing solutions that address animal health challenges. Elanco engages in research and development to advance animal well-being and strives for sustainable practices and diversity in its operations worldwide. The company is known for products like Credelio Quattro, a canine oral parasiticide, and maintains a commitment to enhancing food and companionship enrichment through its Healthy Purpose™ program.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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