Senior Manager, Labeling & Regulatory Affairs

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . 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 approval withdrawals) and labeling update for all products including mature products of which contents meet the regulatory requirements by exerting the high expertise and teamwork depend on scientific knowledge and regulatory experience. Conduct checks based on the regulatory affairs regarding the product packaging materials. Offer suggestions regarding the information providing materials such as promotions, etc. from the viewpoints of the labeling and its interpretation or communication with regulatory authorities up to approvals. Roles & responsibilities Perform following roles and take responsibilities. In addition, confirm that staffs fulfill the following roles properly, and provide them necessary support after sharing all staffs’ responsibilities. Engage internal and external stakeholders to lead to resolve and to coordinate issues in relation to the work undertaken by the project or department. Development Stage: Prepare a draft of target labeling while referring protocols and labeling of competing products. Obtain agreement for the target labeling from stakeholders in cooperation with the Regulatory Strategy Lead. Approval Application/ Review Stage: Contribute to the optimal labeling strategy. Prepare the best labeling draft after assessing up-to-date information, problems, and risks, and sharing the information with stakeholders. Obtain agreement for the final draft labeling from stakeholders such as Development team, Global, Marketing, or Senior management, etc. Consider the scenario regarding the possibility of acceptance of regulatory authorities and enhance predictability by providing options (solutions). Support for Global Applications (Provision of CPP, etc.): Regarding the requirements for the global application strategy, obtain global agreement on the possible support to align with regulatory in Japan. Prepare necessary documents in order to obtain CPP, etc., and carry out procedures with the regulatory authorities/ embassies of various nations. Maintenance of Marketed Products: Submit post-marketing applications and notifications (approval applications without clinical/CMC data, transfer of approvals, and approval withdrawals). As for the approval applications without clinical/CMC data, examine