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 trends
Experience
Up to 5 years in Global Regulatory Affairs, preferably within Post-approval CMC Life Cycle Management.