Global Regulatory Project Lead - Biologicals

Elanco•Indianapolis, IN

22h

About The Position

The Global Regulatory Project Lead is a key individual contributor who guides regulatory strategy for novel farm and companion animal biological products. The role serves as the dedicated regulatory expert on global development project teams, shaping product development and leading direct negotiations with agencies such as the USDA’s Center for Veterinary Biologics (CVB). The position works across functions including Global Research and Development, Sales and Marketing, Supply Chain, Manufacturing and Quality, Finance, and Technical Services, and supports successful submissions in the United States, European Union, and other first-wave countries. The role requires strategic leadership in complex agency interactions and cross-functional collaboration, with particular emphasis on CVB submissions. The position also contributes to regulatory plans for clinical trials and provides technical leadership for the Quality, Safety, and Efficacy components of regulatory submissions. 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 biologicals.
Demonstrated experience leading direct submissions and negotiations with regulatory agencies; experience with the USDA Center for Veterinary Biologics is strongly preferred.
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 USDA-CVB regulatory experience with both farm animal and companion animal products.
Experience navigating novel regulatory pathways for innovative products.
Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
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 CVB submissions.
Serve as the regulatory subject matter expert on development teams, representing regulatory perspectives and providing risk/benefit evaluations to guide project strategy.
Act as the primary point of contact for regulatory agencies and lead direct agency engagements.
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 health, safety, and environment policies.

Benefits

Multiple relocation packages.
Two weeklong shutdowns in the United States, in mid-summer and at year-end, in addition to PTO.
Eight-week parental leave.
Nine Employee Resource Groups.
Annual bonus offering.
Flexible work arrangements.
Up to 6% 401(k) matching.
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.