Sr Scientist - Global Regulatory Project Lead - Farm Animal

Elanco•Indianapolis, IN

1d•$118,000 - $197,000•Hybrid

About The Position

The Global Regulatory Project Lead is a key individual contributor who guides regulatory strategy for novel farm and companion animal products in Elanco’s innovation pipeline. The role serves as the regulatory expert on global development teams, shapes product development, leads direct negotiations with agencies such as the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM), and supports successful submissions in the United States, European Union, and other first-wave countries. The position works across functions including Global Research and Development, Sales and Marketing, Supply Chain, Manufacturing and Quality, Finance, and Technical Services. It focuses primarily on CVM/FDA submissions and requires strategic agency engagement, cross-functional influence, and assessment of regulatory risks and opportunities. The role is US-based and may be located at Elanco’s Global Headquarters in Indianapolis, Indiana, on a hybrid basis, or be remote for the right candidate. Travel is 10–25%.

Requirements

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, including direct regulatory affairs experience in veterinary pharmaceuticals.
Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for experience with the U.S. FDA 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.

Nice To Haves

Direct regulatory experience with both farm animal and companion animal products.
Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
Experience navigating novel regulatory pathways for innovative products.
Strong understanding of risk assessment and risk management fundamentals.
Knowledge of Continuous Improvement methodologies such as Six Sigma or Lean.

Responsibilities

Guide the design and development of global regulatory strategy for development projects, primarily focusing on CVM/FDA submissions.
Serve as the regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
Act as the primary contact for regulatory agencies and lead direct engagements, including pre-submission meetings and negotiations.
Partner with R&D to develop and implement clinical trial submission plans aligned with the overall regulatory strategy.
Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections of regulatory submissions.
Identify and communicate project-specific regulatory risks and opportunities to development teams and leadership.
Comply with company local and global policies, including quality frameworks, the Code of Conduct, anti-discrimination, harassment, and HSE policies.

Benefits

Multiple relocation packages
Two weeklong US shutdowns, in mid-summer and at year-end, in addition to PTO
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Company bonus eligibility for full-time equivalent employees, depending partly on company and individual performance
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities