Company OverviewGlobal CRO
Job Description・Participate in regulatory and/or clinical trial project teams as required.
・Plan and track designated project activities including financial tracking under supervision
・Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
・Be able to solve the problems in pro-active and timely manner by identifying the deficiencies in the existing processes and procedures and providing the possible solutions
・Work closely with Process/Project Management team to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure dept expertise and to meet department goals.
・Specific Regulatory Submission team activities include (but are not limited to)
・Input into Preparation, compilation and submission of CT /IND, MAA I NOA, Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation, medical device documentation, Readability testing
・Input into label review, translation requirements, fee requirements etc ・Input to the Regulatory Intelligence function
Requirements・Knowledge of relevant regulations regarding drug development
・High business level English; Fluency in Japanese
・Previous experience in new drug development and regulatory submissions (5 years)
・High problem-solving skill, project management skill, leadership quality