Job Description · Contribute to regulatory events in Japan such as CTN, PMDA consultation and JNDA · Contribute to Drug Metabolism and Pharmacokinetics (DMPK) and CP sections in the regulatory documents such as JCTD and JIB ·
Head of Preclinical Development YOUR TASKS AND RESPONSIBILITIES: Oversee and support the following; Prepare the preclinical part of J-NDA and PAA dossiers (efficacy pharmacology, safety pharmacology, DMPK and toxicology) for successful registration of Bayer products in Japan