Job Description
Description
Contribute to developing valuable new drugs and business continuity by providing and implementing optimal/valuable labeling and regulatory strategy in order to achieve BMSKK business target. For that objective, execute the following tasks;
Have a deep knowledge of up-to-date labeling related information and finalize the highly valued labeling through providing and implementing appropriate labeling strategy in each stage of development, preparation of applications, and approval review by exerting the high expertise and teamwork.Provide necessary support (CPP, etc.) in order to utilize information regarding the approvals and labeling in Japan for global applications.Submit appropriate post-marketing applications, notifications (approval applications without clinical/CMC data, transfer of approvals, and approvals withdrawals) and labeling update for all products including mature products of which contents meet the regulatory req...