Feed Additive Regulatory Specialist

Responsibilities

• Oversee lifecycle management for the US feed additive portfolio, providing expert regulatory guidance on promotional materials and ensuring all commercial activities remain compliant.
• 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.
• 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.
• Ensure all regulatory activities and documentation adhere to Elanco’s Quality Management System (QMS), SOPs, and industry best practices.

Requirements

• 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).

Qualifications

• Education: Bachelor’s degree in Chemistry, Biochemistry, Animal Science, or an equivalent scientific discipline.
• 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).

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.

Pay

Competitive salary based on experience and qualifications.

Schedule

Hybrid Work Environment with 10% travel.

Benefits

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