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

Job Summary

This role is ideal for a Pharmacist, Chemist, or Biologist eager to manage and expand global product authorizations, focusing primarily on chemically defined active ingredients. The Regulatory Affairs Manager will independently plan and oversee all regulatory processes for medicinal products (and potentially medical devices) globally, including managing life-cycle procedures (MRP, DCP, national) within Europe. Key responsibilities involve creating and updating dossiers (Modules 2 and 3), revising product information texts (Module 1), and reviewing documentation from contract manufacturers. Candidates must possess professional experience in drug authorization, expertise in European submission procedures, and proficiency with eCTD tools like docuBridge. This full-time, permanent position in Hamburg offers an opportunity to join a fast-growing, international company and lead critical technology transfer projects, requiring a structured, precise, and solution-oriented approach.