Associate Director, Regulatory Affairs – Biologics
Elanco
June 25, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Your Role
As Associate Director, Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. This role guides regulatory activities across development and lifecycle management, partnering with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.
Your Responsibilities
- Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management
- Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies
- Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation
- Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management
- Partner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goals
What You Need To Succeed (Minimum Qualifications)
- Bachelor’s degree in a scientific or technical discipline (required)
- Minimum 5 years of Regulatory Affairs experience in biologics, vaccines, biotechnology, pharmaceutical, or other regulated life science environments
- Experience supporting regulatory strategy, submissions, health authority interactions, or agency responses
- Knowledge of biologics development, manufacturing processes, and product lifecycle management
- Ability to work cross-functionally and influence decisions in a matrixed environment
What Will Give You a Competitive Edge (Preferred Qualifications)
- Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related regulatory environments
- Biologics CMC Regulatory Affairs experience
- Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH requirements
- Experience with manufacturing changes, tech transfer, or post-approval regulatory activities
- Experience supporting global or multi-regional regulatory programs
As Associate Director, Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. This role guides regulatory activities across development and lifecycle management, partnering with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.
Your Responsibilities
- Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management
- Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies
- Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation
- Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management
- Partner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goals
What You Need To Succeed (Minimum Qualifications)
- Bachelor’s degree in a scientific or technical discipline (required)
- Minimum 5 years of Regulatory Affairs experience in biologics, vaccines, biotechnology, pharmaceutical, or other regulated life science environments
- Experience supporting regulatory strategy, submissions, health authority interactions, or agency responses
- Knowledge of biologics development, manufacturing processes, and product lifecycle management
- Ability to work cross-functionally and influence decisions in a matrixed environment
What Will Give You a Competitive Edge (Preferred Qualifications)
- Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related regulatory environments
- Biologics CMC Regulatory Affairs experience
- Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH requirements
- Experience with manufacturing changes, tech transfer, or post-approval regulatory activities
- Experience supporting global or multi-regional regulatory programs