Feed Additive Regulatory Specialist

Elanco; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Relocation packages

8 weeks parental leave

Annual bonus offering

Flexible work arrangements

Up to 6% 401k matching

Job summary

Elanco seeks a Feed Additive Regulatory Specialist to lead regulatory affairs for the US feed additive and nutritional health portfolio. You will define registration requirements (CMC, Safety, Efficacy) and guide project teams to meet submission standards while ensuring alignment with US federal and state regulations.

You’ll collaborate with global technical functions and the US Affiliate to support post‑approval mandates, promotional material reviews, and interactions with FDA/USDA, maintaining

Qualifications

• Bachelor's degree in a scientific discipline. CMC, Safety, Efficacy knowledge preferred.
• Experience with US regulatory submissions for nutrition/ feed additives and interaction with agencies like FDA/USDA.
• Strong project leadership and ability to coordinate cross-functional teams through complex regulatory processes.

Responsibilities

• Oversee lifecycle management for US feed additive portfolio and ensure compliant promotional materials.
• Define registration requirements across CMC, Safety, Efficacy; guide teams to meet submission standards.
• Serve as primary regulatory contact with authorities and collaborate with global teams and industry groups.
• Ensure documentation aligns with Elanco’s QMS and SOPs across all regulatory activities.

Skills

Regulatory knowledge

Cross-functional leadership

Submission management

Regulatory liaison

Education

Bachelors in Chemistry/Biochemistry/Animal Science

Tools

Veeva Vault RIM

Job description

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: 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.

Preferred Qualifications

• 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).
• 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 proficiency in regulatory information management systems (e.g., Veeva Vault RIM) and electronic submission platforms.

Additional Information

• Travel: 10% or less
• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment

Elanco Benefits and Perks

• Multiple relocation packages
• Two weeklong shutdowns (mid‑summer and year‑end) in the US (in addition to PTO)
• 8‑week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401k matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.