Feed Additive Regulatory Specialist
HybridIndianapolis, Indiana, United States
Job Summary
Oversee lifecycle management for the US feed additive portfolio, providing expert regulatory guidance on promotional materials and ensuring all commercial activities remain compliant. Define registration requirements for Safety, Efficacy, CMC, and Labeling while guiding cross-functional teams through complex submissions to meet FDA and USDA standards. Serve as the primary regulatory contact with authorities and collaborate with global teams and industry groups like AAFCO to shape policies and ensure internal compliance. Ensure all regulatory activities and documentation adhere to Elanco's Quality Management System and industry best practices. This technical leadership role supports the global animal health portfolio at Elanco's Indianapolis headquarters with a hybrid work environment.
Required Qualifications
- Bachelor's degree in Chemistry, Biochemistry, Animal Science, or an equivalent scientific discipline
- A minimum of 5 years of regulatory experience in the nutritional health, feed additive, or sustainability industry
- Proven experience managing US technical submissions
- Experience interacting with regulatory agencies (e.g., FDA, USDA)
- In-depth knowledge of US registration pathways and requirements for feed additives and nutritional health products
- Knowledge of CMC, Safety, Efficacy, and GRAS
- Demonstrated ability to guide cross-functional project teams through complex regulatory submissions
- Experience managing interactions with agencies like the FDA and USDA
Desired Qualifications
- An advanced degree (Masters or PhD) in a relevant scientific discipline
- Direct experience with specific feed additive categories such as enzymes, probiotics, or products related to sustainability (e.g., methane reduction)
- Demonstrated experience managing complex, non-standard regulatory requests and guiding projects to completion under tight timelines
- Effective negotiation and influencing skills, with experience in direct communications with health authorities and industry associations
- High level of proficiency in regulatory information management systems (e.g., Veeva Vault RIM) and electronic submission platforms
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.