Global Regulatory Project Lead - Biologicals

Elanco•Indianapolis, IN

1d•$118,000 - $197,000

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, helping shape product development and leading direct engagements and negotiations with regulatory agencies, particularly the USDA’s Center for Veterinary Biologics (CVB). The position works across functions to support successful submissions in the United States, European Union, and other first-wave countries.

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; USDA Center for Veterinary Biologics experience 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 strategies for development projects, primarily focusing on CVB submissions.
Serve as the regulatory subject matter expert on development teams and provide risk/benefit evaluations to guide project strategy.
Lead direct engagements with regulatory agencies and act as the primary point of contact.
Partner with R&D to develop and implement clinical trial submission plans aligned with the overall regulatory strategy.
Provide technical leadership on Quality, Safety, and Efficacy sections of regulatory submissions in collaboration with internal stakeholders.
Identify and communicate project-specific regulatory risks and opportunities to development teams and leadership.
Comply with company local and global policies, including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment policies.

Benefits

Multiple relocation packages.
Two weeklong shutdowns in the United States, mid-summer and 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.
Eligibility for medical, dental, vision, and prescription drug benefits.
Flexible benefits, such as healthcare and dependent day care flexible spending accounts.
Life insurance and death benefits.
Certain time-off and leave-of-absence benefits.
Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.