Junior software developer állás, munka

• Gyógyszerek hazai és nemzetközi törzskönyvezési, módosítási és megújítási eljárásainak előkészítése és lebonyolítása (OGYÉI, MRP/DCP).
• Törzskönyvi dokumentációk (CTD modulok) összeállítása, ellenőrzése, hiánypótlások és hatósági válaszok előkészítése.

• Regulatory assessment of raw materials, recipes and nutrient profiles
• Creation and updating of regulatory documentation (e.g. list of ingredients, nutrition information, raw material information)
• Review and approval of labels and communication materials in accordance with EU food law

Define and Execute Strategy: Establish and drive the global regulatory strategy for the Pharmaceutical Business Unit, ensuring direct alignment with our commercial objectives and Testo's 2030 vision....

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.