Regulatory Affairs Specialist - EPA at Elanco in greenfield, Indiana

Job Description:

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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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: Regulatory Affairs Specialist 

As a Regulatory Affairs Specialist at Elanco, you will be an integral part of the team responsible for overseeing regulatory compliance and post-approval management of EPA (Environmental Protection Agency) and NASC (National Animal Supplement Council) products. Your primary focus will involve providing regulatory guidance for promotional materials and labeling development, as well as supporting post-approval activities such as submissions and adverse event reporting. 

Your Responsibilities: 

• Provide regulatory guidance for reviewing and approving promotional materials to support the food animal and pet health business of the Elanco US Affiliate. 




• Fulfill ALRP (Affiliate Labeling Responsible Person) duties for post-approval label changes and collaborate with regulatory innovation for pre-approval label creation. 




• Develop and maintain a comprehensive understanding of regulatory guidelines for EPA and NASC products. 




• Manage all regulatory activities related to assigned products and/or areas to ensure compliance and timely submissions. 




• Collaborate with cross-functional teams internally (Marketing, Legal, Technical, Labeling, etc.) and external partners to promote regulatory awareness and compliance. 

What You Need to Succeed (minimum qualifications): 

• Education: Bachelor’s degree or equivalent. 




• Required Experience: At least 3 years of relevant work experience within the sciences or related areas. 




• Top 2 skills: Strong collaboration skills Self-management skills in an environment with diverse needs and demanding timelines 

What will give you a competitive edge (preferred qualifications): 

• Understanding of the US regulatory landscape, preferably EPA and NASC regulatory requirements 




• Strong oral and written communication skills and attention to detail 

Additional Information: 

• Travel: Up to 10% annually 




• Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (NEW HQ COMING IN 2025 - Indianapolis, IN)

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! 

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 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