Regulatory Affairs Advisor – Veterinary 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. 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!

Position Description:

Join our team at Elanco Animal Health as a Regulatory Affairs Advisor for Biologicals and become a vital part of our mission to bring innovative veterinary products to life! In this dynamic role, you’ll lead the charge in navigating regulatory landscapes, ensuring our products meet the highest standards for safety and effectiveness. As a Regulatory Affairs Advisor, you’ll be at the forefront of driving regulatory strategies and interactions with key stakeholders, including the USDA Center for Veterinary Biologics (CVB). Your expertise will be instrumental in guiding our cross-functional teams to success, as you navigate complex regulations with finesse and creativity.

But that’s not all – you’ll also have the opportunity to cultivate meaningful relationships both internally and externally, collaborating with R&D, manufacturing, quality, and industry groups. Your leadership will inspire innovative solutions and foster a positive work environment, all while ensuring our pipeline thrives and our products maintain their regulatory licenses. Join us in shaping the future of animal health and be part of a team that’s dedicated to making a difference every day!

Functions, Duties, Task:

Key Technical Responsibilities:

• Responsible for having a thorough understanding of the regulations in order to work independently within a cross-functional team.
• Anticipates and resolves complex problems to maintain product to market.
• Subject matter expertise to advise R&D, QC, QA, and Manufacturing on regulatory aspects.
• Ensure inspection readiness from regulatory perspective. Includes oversight of RA review of manufacturing direction templates for alignment with regulatory documents.
• Build tools, systems, and business process to develop best in capabilities.
• Reviews submissions to ensure they are scientifically sound, accurate, and compliant.
• Coordinate, supervise and review commitment responses.
• Actively participates in meetings that drive strategy and outcomes. Includes strategies from innovation through product post-approval.

Key Leadership Responsibilities:

• Proactively search for opportunities for continuous improvement and facilitate implementation of new standards and practices with the ability to think “out of the box”.
• Provide and accept challenge to deliver regulatory solutions and opportunities while creating an innovative culture.
• Work effectively and flexibly within and across all Elanco teams, external collaborators, government agencies, and affiliates to assist in achieving overall Elanco deliverables.
• Create a positive, engaging, and inspiring work environment that is aligned with company objectives.
• Influence others to adopt a different view to create an innovative culture.
• Create an engaging culture with a “Play to Win” mentality and identifying essential wins.
• Excellent interpersonal and communication skills.

Minimum Qualification (education, experience and/or training, required certifications):

• Bachelor’s Degree in a related field of study
• 10 years in a veterinary vaccine manufacturing setting

Additional Preferences:

• Strong understanding of varied regulatory requirements related to veterinary vaccine manufacturing.
• Previous experience in R&D and/or Quality
• Knowledge of Continuous Improvement Six Sigma and Lean Principles
• Experience of working with novel regulatory pathways/mechanisms would be advantageous.

Expected Travel : 10-25%

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.

Learn more here