Manager Regulatory Affairs Global Specialty / Biosimilar Development | Manager Regulatory Affairs Global Specialty / Biosimilar Development (f/m/d)

Job Summary

This role is for a Manager of Global Regulatory Affairs focusing on Specialty and Biosimilar Development. The core responsibility involves the comprehensive lifecycle management of biosimilar projects, including handling post-approval changes, preparing submissions, and generating eCTD sequences using specialized publishing and document management software. A key daily task is maintaining regulatory information in the RIMS, initiating change control processes, and coordinating product information (PI) translations across 25 EU languages. The ideal candidate holds a Master's degree in life sciences and possesses professional experience in Global Regulatory Affairs for Biologics or Small Molecules, coupled with familiarity with FDA and non-EU regulations, and EU medical device regulations. This position offers a unique opportunity to manage complex global dossiers, ensure compliance with EMA and QRD requirements, and actively contribute to departmental continuous improvement initiatives, making it a pivotal role in STADA's global development pipeline.