Global Regulatory Lead, Animal Health Projects

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

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (US)

8-week parental leave

9 Employee Resource Groups

Annual bonus

Job summary

Elanco is seeking a Senior Scientist, Global Regulatory Lead (Project Management) to guide regulatory strategy for novel farm and companion animal products. You will serve as the regulatory expert on global teams, shaping development from inception and negotiating with agencies.

You will collaborate with R&D, QA, safety, and manufacturing to ensure aligned submissions in the US, EU, and other key markets, while navigating risk and opportunity for project success.

Qualifications

• Master's or higher in veterinary medicine or related field.
• At least 10 years of regulatory affairs experience in animal health.
• Direct submissions and negotiations experience with regulatory agencies (CVM preferred).
• Ability to lead cross-functional project teams in a global environment.

Responsibilities

• Guide global regulatory strategy for development projects with focus on CVM/FDA submissions.
• Serve as regulatory subject matter expert on development teams and provide risk/benefit evaluations.
• Lead direct engagements with regulatory agencies (CVM, EMA) including pre-submission meetings.
• Partner with R&D to develop clinical submission plans aligned with regulatory strategy.
• Provide technical leadership on Quality, Safety, and Efficacy sections for submissions.
• Identify regulatory risks and communicate opportunities to teams and leadership.

Skills

Regulatory affairs

Global submissions

Agency negotiations

Cross-functional leadership

Veterinary biology

Education

Master's degree or higher in veterinary medicine or related field

10+ years in animal health regulatory affairs

Job description

Elanco is seeking a Senior Scientist, Global Regulatory Lead (Project Management) to guide regulatory strategy for novel farm and companion animal products. You will serve as the regulatory expert on global teams, shaping development from inception and negotiating with agencies.

You will collaborate with R&D, QA, safety, and manufacturing to ensure aligned submissions in the US, EU, and other key markets, while navigating risk and opportunity for project success.