Senior Associate, Regulatory Affairs

1) review client's development plan and study materials (protocol, IB, etc), perform gap analysis whether the documents meet PMDA's criteria, 2) prepare and submit document package to PMDA, 3) arrange a meeting for client and support to obtain favorable outcome/ PMDA's commitments. 4) communicate with client and clarify the information to be retrieve from PMDA. 5) application of orphan drug designation nd/or Sakigake designation (fast truck application in Japan), 6) oversight ICR projects and prepare routine reports to clients.7) support other consultants to ensure the completion of all deliverables in timely manner.QualificationsMore than 5 years work experience in Pharmaceutical/ CRO industry or healthcare industry. Basic knowledge on drug development, relevant regulation and guidelines, clinical trial operations. English and Japanese communication skills. Negotiation skills with regulatory authorities and clients. Educational back ground: above university graduate. A holder of PhD, RPh qualification preferable. Physically and mentally healthy. Good team work spirit is essential.