Global Regulatory Project Lead, Animal Health

Elanco Tiergesundheit AG; Indianapolis (IN); Hybrid; USD 118,000 - 197,000; Full time

Benefits offered by this job

Relocation packages

Shutdowns in US

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Global Regulatory Project Lead to guide regulatory strategy for novel farm and companion animal products. You will serve as the regulatory expert on global project teams, directing submissions to CVM/FDA and coordinating with cross-functional partners across R&D, Sales, Supply Chain, and Quality.

Based in the US with Hybrid Indianapolis location option, you will negotiate with agencies, lead risk assessments, and ensure timely regulatory approvals to advance our animal health

Qualifications

• 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 regulatory affairs experience in veterinary pharmaceuticals.
• Demonstrated experience leading direct submissions and negotiations with regulatory agencies, especially CVM/FDA.
• Proven ability to lead cross-functional global project teams with excellent communication and negotiation skills.

Responsibilities

• Guide the design and development of the global regulatory strategy for development projects, focusing on CVM/FDA submissions.
• Serve as the regulatory subject matter expert on development teams, providing risk/benefit evaluations to guide strategy.
• Lead direct engagements with regulatory agencies (CVM, EMA) including pre-submission meetings and negotiations.
• Partner with R&D to develop and implement clinical trial submission plans.
• Provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
• Identify and communicate project-specific regulatory risks and opportunities to the team and leadership.
• Ensure compliance with company policies including quality frameworks, Code of Conduct, and HSE policies.

Education

Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field

Tools

Regulatory submission processes

Job description

Elanco is seeking a Global Regulatory Project Lead to guide regulatory strategy for novel farm and companion animal products. You will serve as the regulatory expert on global project teams, directing submissions to CVM/FDA and coordinating with cross-functional partners across R&D, Sales, Supply Chain, and Quality.

Based in the US with Hybrid Indianapolis location option, you will negotiate with agencies, lead risk assessments, and ensure timely regulatory approvals to advance our animal health