Global Regulatory Lead - Veterinary Biologics

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

Benefits offered by this job

Relocation packages

Two shutdowns (mid-summer and year-end

Parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Global Regulatory Project Lead - Biologicals to guide regulatory strategy for farm and companion animal biologics. You will lead CVB submissions and coordinate cross-functional teams across R&D, Sales, Quality, and Manufacturing.

This high-impact role requires a master’s degree in a relevant field, 10+ years of regulatory experience, and proven negotiation skills with agencies. Travel 10–25% is expected.

Qualifications

• Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.
• 10+ years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary biologicals.
• Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the USDA – Center of Veterinary Biologics (CVB).
• Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.

Responsibilities

• Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVB submissions.
• Serve as the dedicated regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
• 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, ensuring alignment with the overall regulatory strategy.
• 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 to the development team and leadership.
• Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.

Skills

Regulatory leadership

Global regulatory strategy

Negotiation with agencies

Cross-functional collaboration

Education

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

Job description

Elanco is seeking a Global Regulatory Project Lead - Biologicals to guide regulatory strategy for farm and companion animal biologics. You will lead CVB submissions and coordinate cross-functional teams across R&D, Sales, Quality, and Manufacturing.

This high-impact role requires a master’s degree in a relevant field, 10+ years of regulatory experience, and proven negotiation skills with agencies. Travel 10–25% is expected.