Junior python 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.

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...

This role reports to the FMC Corporation’s Global Regulatory Sciences group and is part of the Global R&D organization....

• 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.

• Performing post-market surveillance and vigilance activities in accordance with internal procedures and applicable regulations
• Coordination of recalls and field actions as well as establishing and maintaining quality system related workflows, processes and procedures