Associate Director, Regulatory Affairs – Biologics
Elanco
4 days ago
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 across development and lifecycle management. Partner with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.
Responsibilities
- Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management.
- Serve as primary regulatory contact for interactions with health authorities (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 cross-functional stakeholders to align regulatory strategy with program goals.
Minimum Qualifications
- Bachelor’s degree in a scientific or technical discipline.
- 5+ years Regulatory Affairs experience in biologics, vaccines, biotechnology, pharmaceutical, or other regulated life sciences.
- Experience supporting regulatory strategy, submissions, and health authority interactions/agency responses.
- Knowledge of biologics development, manufacturing processes, and product lifecycle management.
- Ability to work cross-functionally and influence decisions in a matrixed environment.
Preferred Qualifications
- Experience in Animal Health, Veterinary Biologics, or Veterinary Vaccines.
- Experience in Biologics CMC Regulatory Affairs.
- Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH regulatory requirements.
- Experience with manufacturing changes, tech transfer, or post-approval activities.
- Experience supporting global/multi-regional regulatory programs.
Benefits (highlights)
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end, US) in addition to PTO; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401(k) matching.
As Associate Director, Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation across development and lifecycle management. Partner with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.
Responsibilities
- Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management.
- Serve as primary regulatory contact for interactions with health authorities (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 cross-functional stakeholders to align regulatory strategy with program goals.
Minimum Qualifications
- Bachelor’s degree in a scientific or technical discipline.
- 5+ years Regulatory Affairs experience in biologics, vaccines, biotechnology, pharmaceutical, or other regulated life sciences.
- Experience supporting regulatory strategy, submissions, and health authority interactions/agency responses.
- Knowledge of biologics development, manufacturing processes, and product lifecycle management.
- Ability to work cross-functionally and influence decisions in a matrixed environment.
Preferred Qualifications
- Experience in Animal Health, Veterinary Biologics, or Veterinary Vaccines.
- Experience in Biologics CMC Regulatory Affairs.
- Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH regulatory requirements.
- Experience with manufacturing changes, tech transfer, or post-approval activities.
- Experience supporting global/multi-regional regulatory programs.
Benefits (highlights)
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end, US) in addition to PTO; 8-week parental leave; annual bonus offering; flexible work arrangements; up to 6% 401(k) matching.