Your Role: Feed Additive Regulatory Specialist The Feed Additive Regulatory Specialist is a technical leadership role responsible for the operational execution of regulatory affairs for Elanco's US Feed Additive and Nutritional Health portfolio. This individual provides the technical expertise required to define registration requirements and ensures that all product development packages align with regulatory expectations.
As a key technical leader, you will play a vital role in the lifecycle management of registered products, guiding project teams to address post-approval mandates and providing critical regulatory guidance for promotional materials. This role acts as a bridge between global technical functions and the US Affiliate, ensuring that Elanco remains compliant with all federal and state regulations while maintaining positive collaborations with regulatory agencies and industry trade groups.
Your Responsibilities: - Regulatory Execution & Commercial Partnership: Oversee lifecycle management for the US feed additive portfolio, providing expert regulatory guidance on promotional materials and ensuring all commercial activities remain compliant.
- Technical Leadership & Project Management: Apply sound scientific approaches to define registration requirements (Safety, Efficacy, CMC, Labeling) and guide project teams by coordinating internal and external resources to meet submission standards.
- Cross-functional Collaboration & External Influence: Serve as the primary regulatory contact with authorities, and collaborate with global teams and industry groups (AAFCO, AFIA) to shape policies and ensure internal compliance.
- Quality & Compliance: Ensure all regulatory activities and documentation adhere to Elanco's Quality Management System (QMS), SOPs, and industry best practices.
What You Need to Succeed (minimum qualifications): - Education: Bachelor's degree in Chemistry, Biochemistry, Animal Science, or an equivalent scientific discipline.
- Experience: A minimum of 5 years of regulatory experience in the nutritional health, feed additive, or sustainability industry, with proven experience managing US technical submissions and interacting with regulatory agencies (e.g., FDA, USDA).
- Technical Expertise: In-depth knowledge of US registration pathways and requirements for feed additives and nutritional health products, including CMC, Safety, Efficacy, and GRAS.
- Project Leadership: Demonstrated ability to guide cross-functional project teams through complex regulatory submissions and manage interactions with agencies like the FDA and USDA.
What will give you a competitive edge (preferred 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.
Additional Information: - Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 9 Employee Resource Groups
- Flexible work arrangements
