This position is responsible for the management of a team of regulatory submissions professionals and/or responsible for timely preparation/coordination of regulatory submissions for a particular project and must work to high standards (governmental, Sponsor, Covance and self) with minimal supervision.
Coach and mentor junior staffs and responsible for monitoring workload and work assignment s
Ensure that Japanese CTN packages are prepared to the required standards by maintaining awareness of current regulatory standards related to CTN submissions and clinical research, and be responsible for providing regulatory consultancy advice on CTN Submissions and ICCC related activities to client companies and/or the Covance project team.
Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.
Understanding of and ability to determine relevance of governmental regulatory processes and regulations in Japan as they pertain to investigational drug regulations in particular.
Minimum of 5 years experience in the Pharmaceutical industry in Regulatory Affairs or Drug
Development, with hands-on Japanese CTN preparation and submissions experience using the appropriate CTN XML software
Excellent communication, organization and planning skills with an attention to detail.
Direct supervisory and project management skills and ability to work independently.