Our partner specializes in the development of biosimilars, aiming to provide high-quality, cost-effective alternatives to branded biologic therapies. Their focus is on expanding access to essential treatments for a range of diseases, improving patient outcomes while maintaining safety and efficacy.

This critical hire sat within a product-facing position that provided best-in-class CMC strategy for assigned products which ensured the development, licensure, and maintenance of the product on the market. This role focused on life-cycle regulatory maintenance for to-be launched and licensed products, inclusive of assessing worldwide regulatory impact from changes, as well as authoring worldwide CMC submissions.