Regulatory Affairs Responsible, External Manufacturing API

The Regulatory Affairs Responsible, External Manufacturing API role at Opella focuses on ensuring regulatory compliance and lifecycle management for the company's external manufacturing Active Pharmaceutical Ingredients (API) network. This position involves acting as a CMC expert to maintain regulatory dossiers, support supply continuity, and execute regulatory strategies across global markets. The role requires collaboration with internal and external stakeholders to manage submissions, assess regulatory impacts, and ensure alignment with manufacturing practices.