Analyst –Global CMC Regulatory
1 week ago
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
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 may 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.
Functions, Duties and Tasks
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 Lead and implement all global CMC submission activities for assigned projects/products, while applying the global strategy into submissions. Ensure the required documentation and any content, quality and/or timelines for global submissions are communicated to the appropriate teams and tracked accordingly Author high-quality CMC documentation for submission, applying CMC global regulatory strategies, assuring regulatory compliance. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trendsCore Competencies:
1 to 3 years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management. 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 right or wrong answer Self-starter, takes initiative Timeline driven Attention to detail Quality and customer focused mindset Strong organization and an ability to multi-task; able to handle multiple projects at different phases of development at the same time-
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