Feed Additive Regulatory Specialist
Elanco
August 18, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
Your Role: Feed Additive Regulatory Specialist
Responsibilities:
- Oversee lifecycle management for the US feed additive portfolio; ensure commercial activities and promotional materials remain compliant.
- Define registration requirements (Safety, Efficacy, CMC, Labeling) using sound scientific approaches; coordinate internal/external resources to meet submission standards.
- Serve as primary regulatory contact with authorities; collaborate with global teams and industry groups (AAFCO, AFIA) to shape policies and ensure internal compliance.
- Ensure regulatory activities and documentation adhere to Elanco’s Quality Management System (QMS), SOPs, and industry best practices.
Qualifications (Minimum):
- Bachelor’s degree in Chemistry, Biochemistry, Animal Science, or equivalent.
- 5+ years regulatory experience in nutritional health, feed additive, or sustainability; proven experience managing US technical submissions and interacting with agencies (e.g., FDA, USDA).
- In-depth knowledge of US registration pathways for feed additives/nutritional health, including CMC, Safety, Efficacy, and GRAS.
- Ability to lead cross-functional teams through complex regulatory submissions and manage interactions with FDA/USDA.
Preferred:
- Masters/PhD in a relevant scientific discipline.
- Experience with feed additive categories (enzymes, probiotics) and/or sustainability-related products (e.g., methane reduction).
- Experience with complex, non-standard regulatory requests; delivery under tight timelines.
- Negotiation/influencing skills with health authorities and industry associations.
- Proficiency with regulatory information management systems (e.g., Veeva Vault RIM) and electronic submission platforms.
Additional Information:
- Travel: 10% or less. Location: Indianapolis, IN (Hybrid).
Benefits and Perks: Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus; flexible work; up to 6% 401K matching.
Responsibilities:
- Oversee lifecycle management for the US feed additive portfolio; ensure commercial activities and promotional materials remain compliant.
- Define registration requirements (Safety, Efficacy, CMC, Labeling) using sound scientific approaches; coordinate internal/external resources to meet submission standards.
- Serve as primary regulatory contact with authorities; collaborate with global teams and industry groups (AAFCO, AFIA) to shape policies and ensure internal compliance.
- Ensure regulatory activities and documentation adhere to Elanco’s Quality Management System (QMS), SOPs, and industry best practices.
Qualifications (Minimum):
- Bachelor’s degree in Chemistry, Biochemistry, Animal Science, or equivalent.
- 5+ years regulatory experience in nutritional health, feed additive, or sustainability; proven experience managing US technical submissions and interacting with agencies (e.g., FDA, USDA).
- In-depth knowledge of US registration pathways for feed additives/nutritional health, including CMC, Safety, Efficacy, and GRAS.
- Ability to lead cross-functional teams through complex regulatory submissions and manage interactions with FDA/USDA.
Preferred:
- Masters/PhD in a relevant scientific discipline.
- Experience with feed additive categories (enzymes, probiotics) and/or sustainability-related products (e.g., methane reduction).
- Experience with complex, non-standard regulatory requests; delivery under tight timelines.
- Negotiation/influencing skills with health authorities and industry associations.
- Proficiency with regulatory information management systems (e.g., Veeva Vault RIM) and electronic submission platforms.
Additional Information:
- Travel: 10% or less. Location: Indianapolis, IN (Hybrid).
Benefits and Perks: Multiple relocation packages; two weeklong shutdowns; 8-week parental leave; annual bonus; flexible work; up to 6% 401K matching.