Regulatory Affairs Specialist Medical

Regulatory Affairs Specialists in the medical and pharmaceutical sector prepare, submit, and manage regulatory approval applications for drugs, biologics, and medical devices to national and regional authorities including EMA, BfArM, ANSM, FDA, and GCC health authorities, ensuring products meet all regulatory requirements for marketing authorization. They interpret regulatory guidelines, prepare technical documentation (CTD for pharmaceuticals, Technical Files for medical devices under EU MDR), and manage ongoing regulatory compliance throughout product lifecycles.