Associate Director, Regulatory Affairs - Biologics

Your Role As 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 Responsibilities Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management activities Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management Partner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goals What You Need To Succeed (minimum Qualifications) Education: Bachelor’s degree in a scientific or technical discipline required Experience: Minimum of 5 years of Regulatory Affairs experience within biologics, vaccines, biotechnology, pharmaceutical, or other regulated life science environments Experience supporting regulatory strategy, regulatory submissions, health authority interactions, or agency responses Knowledge of biologics development, manufacturing processes, and product lifecycle management Ability to work cross-functionally and influence decisions in a matrixed environment What Will Give You a Competitive Edge (preferred Qualifications) Experience in Animal Health, Veterinary Biologics, Veterinary Vaccines, or related regulatory environments Experience in Biologics CMC Regulatory Affairs Familiarity with USDA-CVB, FDA-CVM, EMA, and VICH regulatory requirements Experience supporting manufacturing changes, tech transfer, or post-approval regulatory activities Experience supporting global or multi-regional regulatory programs 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% 401(k) matching Company bonus based on company and individual performance 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 Well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities) Equal Opportunity Employer 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. #J-18808-Ljbffr Elanco