Associate Director, Regulatory Affairs - Biologics

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 RoleAs Associate Director, Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. This role guides regulatory activities across development and lifecycle management, partnering closely with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.The ideal candidate brings experience in biologics, vaccines, biotechnology, or pharmaceutical regulatory affairs and has supported regulatory strategy, health authority interactions, and regulatory submissions. Experience in Animal Health is valued but not required.This is an opportunity to apply your biologics regulatory expertise to innovative development programs while helping advance products that improve animal health globally.Your ResponsibilitiesLead regulatory strategy for biologics and vaccine programs across development and lifecycle management activitiesServe as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agenciesDrive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentationProvide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle managementPartner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goalsWhat You Need to Succeed (minimum qualifications)Education: Bachelor’s degree in a scientific or technical discipline requiredExperienced product Regulatory Affairs professional with 5+ years of direct RA experience, ideally biologics/vaccines or CMC, who has owned regulatory strategy, submissions and agency interactions and is either Indianapolis-based or clearly willing to relocate.Experience supporting regulatory strategy, regulatory submissions, health authority interactions, or agency responsesKnowledge of biologics development, manufacturing processes, and product lifecycle managementAbility to work cross-functionally and influence decisions in a matrixed environmentWhat Will Give You a Competitive Edge (preferred qualifications)Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related regulatory environmentsExperience in Biologics CMC Regulatory AffairsFamiliarity with USDA-CVB, FDA-CVM, EMA, and VICH regulatory requirementsExperience supporting manufacturing changes, tech transfer, or post-approval regulatory activitiesExperience supporting global or multi-regional regulatory programsDon't meet every single requirement? Studies have shown underrecognized 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 matchingFull-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees.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.#LI-RH1Elanco 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.SummaryLocation: Indianapolis, INType: Full time