Company OverviewGlobal pharmaceutical company which focus on speciality care area
Job Description1.Preparation for new drug applications (NDA)
(1)Creation of application dossiers of quality part with CTD format and correspondence with the Japanese regulatory agency, PMDA.
(2)Evaluation of drug product candidates for developing in Japan, and build development strategies.
2.Regulatory compliance of commercial products
(1)Preparation for variation applications and correspondence with the PMDA.
(2)Documentation for minor change notification.
3.Works related to GMP
(1)Support of foreign manufacturing site accreditation applications
(2)Support of pre-approval GMP inspections to foreign manufacturing sites
4.Works related to investigational medicinal products (IMP)
(1)Importation of IMP for local clinical trials
(2)Out sourcing of 2nd packaging and labeling of IMP
Needs communication skill in English in order to communicate with the Global R&D and foreign manufacturing sites.