Associate Manager - CMC Regulatory
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 partnership with internal groups in R&D, Quality, Manufacturing and 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, while applying the global strategy into submissions.