Associate Manager - CMC Regulatory Writing

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!

Your Role:

The purpose of Associate Manager, Global 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 drugs with global regulatory agencies.  This role also executes 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:


* Design/develop CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance


* Maintain a positive collaboration and partnership with internal groups in R&D, Quality and manufacturing


* Maintain a positive business collaboration and partnership with global regulatory business partners of Elanco


* Lead CMC submission preparation to provide high quality submissions to multiple geographies


* Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams

What You Need to Succeed (minimum qualifications):


* Degree in Science (MSc, B.

Pharm/M.Pharm, Postgraduate in Vet Sciences etc.,) 


* 5+ years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management


* Understanding of the cGMP requirements


* Experience working with Regulatory Information Management Tools and Systems

What will give you a competitive edge (preferred qualifications):


* Strong knowledge of FDA/CVM and EMA guidelines


* Experience with CMC registrations in the US and/or Europe


* Strong communication skills, both written and oral


* Ability to make decisions when there is no clear ...