Global Regulatory Strategy Lead — Animal Biologics

Elanco; Indianapolis (IN); On-site; USD 118,000 - 197,000; Full time

Benefits offered by this job

Relocation packages

Two shutdowns in US (mid-summer, year‑

PTO

8-week parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401(k) matching

Job summary

Elanco is seeking a Global Regulatory Project Lead - Biologicals to guide regulatory strategy for farm and companion animal products. You will lead global submissions, negotiate with agencies, and coordinate with R&D, QA, and other functions to align on development plans.

This role requires a strategic, communicative leader capable of navigating complex regulatory landscapes. You will interact with US, EU, and first-wave markets, travel 10–25%, and contribute to a high-impact regulatory program

Qualifications

• Master’s degree or higher in veterinary medicine or related field.
• 10+ years in animal health with regulatory affairs experience in veterinary biologics.
• Experience leading submissions and negotiations with regulatory agencies, preferably USDA CVB.

Responsibilities

• Guide global regulatory strategy for development projects focusing on CVB submissions.
• Act as regulatory expert on cross-functional development teams and negotiate with agencies.
• Collaborate with R&D to develop clinical submission plans and ensure alignment with strategy.
• Provide leadership on Quality, Safety, and Efficacy sections for submissions.
• Identify regulatory risks and communicate opportunities to leadership.
• Ensure compliance with company policies and health, safety, and environment guidelines.

Skills

Regulatory leadership

Cross-functional collaboration

Negotiation

Strategic thinking

Education

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

Job description

Elanco is seeking a Global Regulatory Project Lead - Biologicals to guide regulatory strategy for farm and companion animal products. You will lead global submissions, negotiate with agencies, and coordinate with R&D, QA, and other functions to align on development plans.

This role requires a strategic, communicative leader capable of navigating complex regulatory landscapes. You will interact with US, EU, and first-wave markets, travel 10–25%, and contribute to a high-impact regulatory program