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 evidence and propose a preparation method of application documents by him/herself. Cooperate with global teams and submit query responses in order to obtain approvals in a proper period. If necessary, cooperate with the Global Labeling team and contribute to revisions of labeling, and ensuring compliance. Lead the labeling strategy with cross-functional teams. Advice, etc. based on the regulatory affairs: Conduct checks based on the regulatory affairs regarding the product packaging materials and contribute to ensuring compliance in cooperation with the GPS department. 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 Coaching and training of staffs: Support colleagues and if necessary, negotiate and solve problems. Building and improving the organization: Understand the policies of the company and organization, play a role in their implementation. Leads the formulation and improvement of processes to facilitate inter-organizational cooperation. Required knowledge/skills Have the following high level knowledge and skills; Specialized scientific knowledge and knowledge of R&D process Latest regulatory related knowledge (Pharmaceuticals and Medical Devices Law, ministerial ordinance, guidelines, etc.) and experience of regulatory related work. Knowledge of local and global organization and its role which is related to labeling and mature products Leadership skills Communication and teamwork skills Results orientation Strategic negotiation skills Problem-solving ability Analytical thinking Facilitation skills Capacity to environmental changes (external/internal) Enables to assign tasks to priority orders and handle a plurality of important projects simultaneously English communication skills (Can attend audio conference with global teams, lead the meeting, explain requirements in Japan, and obtain agreement by him/herself.) English communication skill for e-mail If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol