Advisor – Global Regulatory Affairs CMC Biologicals

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!

Position Description: 

The Advisor, CMC Regulatory Affairs – Biologicals for Elanco Animal Health is responsible for providing regulatory guidance resulting in comprehensive, cohesive, and compliant submissions and interactions to maintain product registrations and product availability.  The individual in this role interacts with regulators and internal stakeholders to drive regulatory solutions.   

 

The Advisor, CMC Regulatory Affairs – Biologicals will initiate strategies and follow-up on process improvements and commitments.  Additionally, the individual in this role will focus on interacting positively while developing relationships with internal and external stakeholders including Manufacturing, Quality, R&D, and third party and trade association groups.

The individual in this role is expected to perform key leadership responsibilities, which provide innovative solutions, a positive and motivating work environment, to ultimately deliver the Elanco pipeline and maintain established product registrations and regulatory availability. 

 

Functions, Duties, Task: 

Key Technical Responsibilities: 


* Responsible for having a thorough understanding of the regulations to work independently within a cross-functional team.   



* Anticipates and resolves complex problems to maintain product to market. 



* Subject matter expertise to advise QC, QA, and Manufacturing on regulatory aspects.  



* Ensure inspection readiness from regulatory perspective.   



* Build tools, systems, and business processes to develop best capabilities. 



* Writes and reviews submissions to ensure they are scientifically sound, accurate, and compliant in close collaboration with Subject Matter Experts. 



* Coordinate, supervise and review commitment responses. 



* Actively participates in meetings that drive strategy and outcomes.   

 

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”. 



* Deliver...