Regulatory Affairs Manager - Pharmaceuticals | Regulatory-Affairs-Manager (m/w/d) - Arzneimittel (Pharmazeut, Chemiker, Biologe o. ä.)

Job Summary

This role is ideal for a Pharmaceutical Scientist, Chemist, Biologist, or similar professional eager to join a dynamic, international scale-up environment focused on global expansion. The Regulatory Affairs Manager will independently plan and manage all regulatory procedures, including change notifications and renewals, primarily for medicinal products (chemically defined active substances) and potentially medical devices, across the EU and globally. Key responsibilities include managing European procedures (MRP, DCP, national) within the product life-cycle, creating and updating dossiers (Modules 2 and 3), and reviewing documentation from active substance or contract manufacturers. The successful candidate must possess a degree in Pharmacy or a related natural science field and have multi-year professional experience in drug approval processes. Expertise in eCTD tools (like docuBridge) and structured, solution-oriented project management is essential for success in this challenging and rewarding position.