Associate Director, Regulatory Affairs – Biologics

Elanco•Indianapolis, IN

About The Position

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 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.

Requirements

Bachelor’s degree in a scientific or technical discipline required
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

Nice To Haves

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

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

Benefits

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
Company bonus (depending partly on company and individual performance)
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)