Feed Additive Regulatory Specialist

Indianaagconnection; Indianapolis (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns

Parental leave (8 weeks)

401K matching

Flexible work arrangements

Job summary

Elanco is seeking a Feed Additive Regulatory Specialist in Indianapolis, IN. Hybrid work arrangements; travel 10% or less. You will lead regulatory affairs for the US feed additive portfolio, guiding registration activities with FDA/USDA and ensuring all submissions meet regulatory standards.

You will collaborate with global teams, support post-approval mandates, and influence labeling and promotional materials while aligning with Elanco's QMS and regulatory expectations.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Animal Science, or an equivalent scientific discipline.
• Minimum of 5 years regulatory experience in nutritional health, feed additives, or sustainability with US submissions.
• Deep knowledge of US registration pathways for feed additives, including CMC, Safety, Efficacy, and GRAS.
• Experience interacting with agencies such as FDA and USDA.
• Ability to lead cross-functional teams through complex regulatory submissions.

Responsibilities

• Oversee lifecycle management of the US feed additive portfolio and guidance on promotional materials.
• Define registration requirements (Safety, Efficacy, CMC, Labeling) and coordinate submissions.
• Act as regulatory contact with authorities and collaborate with global teams and industry groups.
• Ensure compliance with Elanco's Quality Management System (QMS) and SOPs.

Skills

Regulatory compliance

FDA/USDA liaison

CMC/Safety/Efficacy

GRAS knowledge

Project leadership

Education

Bachelor's degree in Chemistry/Biochemistry/Animal Science

Tools

Veeva Vault RIM

Electronic submissions

Job description

### Job Details#### Job Title:Feed Additive Regulatory Specialist#### Location:,, ,#### Company:#### Industry Sector:#### Industry Type:#### Career Type:#### Job Type:Full Time#### Minimum Years Experience Required:N/A#### Salary:### Get Job Alerts**Career Type:****Country:** USAI agree to receive alerts from and to the .Your alert was created successfully.x## General Alert Saved* The listings below are jobs matching the criteria you've selected for your General Alert on.Criteria selected was:* General alert saved for .* General alert notifications will be sent weekly on Monday.* Please note that you can only have one general alert active at any given time. Creating a new general alert will override an existing general alert.* Visit the to manage your alerts# Feed Additive Regulatory Specialist| Number of Years Experience: | Minimum Education Completed: | || Education Major / Discipline Category: | Most Recent / Current Occupation: | |**At Elanco (NYSE: ELAN) - it all starts with animals!****As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.****At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.****Making animals' lives better makes life better - join our team today!****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).* **Top Skills:*** **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:*** **Travel:** 10% or less* **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)* 8-week parental leave* 9 Employee Resource Groups* Annual bonus offering* Flexible work arrangements* Up to 6% 401K matchingElanco 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 statusElanco 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.To apply please click on APPLY TO THIS POSITIONJob Post Date: 07/07/26Here are some other jobs you may be interested in applying for.| | || - | - || Elanco Indianapolis, Indiana | Elanco Indianapolis, Indiana || Elanco Indianapolis, Indiana | |1 person is interested in this job.