Description
The Regulatory Affairs Manager will provide technical and project leadership across one or more regions, offering regulatory affairs expertise, client interface, strategic regulatory intelligence, and guidance for product development from preclinical stages through registration and product optimization. The role also supports CMC commercial supply, external QC testing, change controls, deviations, OOS investigations, stability, analytical method lifecycle, and regulatory submission preparation. The position requires a master’s degree in chemistry, pharmaceutical sciences, bioengineering, or a related pharmaceutical or biotechnology discipline, strong expertise in biological drug substance and drug product manufacturing, analytical method development and validation, process validation, and statistics, along with fluent English and knowledge of GMP and ICH regulations.
