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This position is responsible for management of Global Innovation with a focus on CMC Regulatory matters in projects at various stages of development specifically developing globally minded regulatory strategies for innovation projects, driving results in cross functional teams to execute on the strategy, leading discussions with regulatory authorities where appropriate, oversee submission preparation, complete the compilation and meet the reporting requirements for the registration/approval of new animal drug with global regulatory agencies, and successful transfer to lifecycle management processes.
This position will be a leader and decision maker that helps drive Innovation through the pipeline to registration and commercialization at the project, strategic and organizational level from a Global Regulatory CMC perspective. Leading through meaningful partnerships and expert knowledge to navigate risk and complexity is expected. Strong scientific background and demonstrated Global Regulatory CMC knowledge required. Expert in EU animal health pharmaceutical regulations preferred; additional experience with US FDA-CVM regulations desirable.
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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
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