Senior Scientist, Global Regulatory Lead

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $118k - $197k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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Elanco

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1954

🌾 Agriculture

💊 Pharmaceuticals

🧬 Biotechnology

💰 Grant on 2017-05

Agriculture • Pharmaceuticals • Biotechnology

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 the global regulatory strategy for development projects • Serve as the dedicated regulatory subject matter expert on development teams • Act as the primary point of contact for and lead direct engagements with regulatory agencies • Partner with R&D to develop and implement clinical trial submission plans • Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions • Proactively identify and communicate project-specific regulatory risks and opportunities

🎯 Requirements

• A 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, with direct regulatory affairs experience in veterinary pharmaceuticals • Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for 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

🏖️ 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