Associate Director, Regulatory Affairs - Biologics

Your Role Associate Director, Regulatory Affairs – Biologics Lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation. Responsibilities Lead regulatory strategy across development and lifecycle management activities. Serve as 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) Bachelor’s degree in a scientific or technical discipline. 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. Benefits and Perks Multiple relocation packages. Two week‑long 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‑matching 401(k). Vacation benefits. 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, employee clubs and activities). 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 other legally protected status. #J-18808-Ljbffr