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 energetic 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: Associate Manager - CMC Regulatory
The purpose of Associate Manager, CMC Regulatory, is to work cross functionally with Elanco manufacturing and quality to develop regulatory strategy,
oversee submission preparation and meet the reporting requirements for the maintenance of registrations/approvals of new animal drug with global regulatory agencies. These roles also execute CM&C; regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products. The person must have a strong knowledge of FDA/CVM and EMA guidelines with the understanding of developing regulatory strategy in the other major geographical regions.
Your Responsibilities:
- Proven track record of overseeing end to end Life cycle management (LCM) of Small/Large Molecules/Complex dosage forms/Sterile preparations/Products derived from Biotechnology/Fermentation and Specialized dosage forms etc.,
- Design/develop CMC regulatory strategy for marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
- Maintain a positive collaboration and partn