ED11311_資深醫藥法規專員Regulatory Affairs Senior Specialist

Experience: 1.Has more than 5+ years R&D experience. Experiences in combination products, e.g. injection, nasal spray or MDI is a plus。 2.Experiences in U.S. and European filing。 3.Experiences in medical device dossier preparation is a plus。 Qualifications: 1.Solid scientific and technical background with excellent communication, interpersonal and organizational skills。 2.Proficient in product development to drug products。 3.Broad knowledge about the FDA or EMA regulatory requirements for drug product and capable of seeking advice and guidance internally and externally as needed。 4.Highly motivated, capable of working independently and also be a good coordinator among cross functional teams。 5.Flexible, hard-working, is capable of managing multiple complex projects at any given time。 6.Excellent planning, time management, presentation, and organization skills。