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 rich in diversity. 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. High-level description; including manage team/individuals or not Contribute to developing valuable new drugs by providing and implementing optimal regulatory strategy in order to achieve BMSKK business target. For that objective, have a deep knowledge of up-to-date regulatory affairs and improve the quality of communication with regulatory authorities (PMDA/MHLW). In addition, provide mitigation plans for regulatory risks in order to deal with unforeseen situation in the development of new drugs. Roles & responsibilities Play following roles and take responsibilities at each phase in the life cycle of the BMSKK asset; Development stage: Provide appropriate input from a regulatory perspective to the new drug development plan, and thereby contribute to prepare an appropriate development plan. Contribute the development team in order to ensure that the J-HAs (PMDA, MHLW) accept clinical study plans and the clinical studies are initiated as planned. Decide whether J-HA interactions (PMDA consultation, Preliminary meeting etc.) are needed. When it is decided that a J-HA interaction is needed, prepare a consultation strategy to ensure that the proposed development plan is accepted by the J-HA. Identify the regulatory risks and notify all relevant colleagues of these risks, and propose risk minimization or mitigation plans and discuss them with relevant personnel in a timely fashion. Provide appropriate advice to ensure that query responses related to CTNs and/or JNDA/sJNDA filing can be submitted within the deadlines, and to ensure that the responses submitted are high-quality responses that will not provoke additional queries. Collaborate with the GRL regarding the preparation of the regulatory strategy, and keep good relationship and well communication with all relevant GRL/Global team colleagues. Approval application/review stage: Take the lead on the work that is required to obtain, for example, Orphan drug or Priority review designations. Lead the JNDA team to complete the JNDA/sJNDA filing as planned in accordance with preparation timeline of approval data. Determine whether a pre-JNDA consultation should be held. If it is determined that a pre-JNDA consultation is needed, then prepare consultation strategies to ensure that the regulatory authorities accept proposed development plan. Manage teams in order to submit query responses in a timely manner without having impacts on application period. Identify problems at an early stage during the JNDA/sJNDA review and lead the preparation of either resolutions or alternative plans. Collaborate with the GRL regarding the JNDA/sJNDA review plans and progress, and maintain good relationship and well communication with all relevant GRL/Global team colleagues. Required level of responsibilities of Regulatory Strategy Senior Manager are as follows; Lead regulatory discussions regarding the regulatory strategy for the product in charge with cross-functional teams and support them. Mentor Manager and Senior Specialist. Level of influence inside the company: Can provide professional advices as a regulatory expert. Level of influence outside the company: Can lead discussions with J-HA officers. Level of influence globally: Can collaborate with the Global Regulatory Strategy TA Directors and move the work forward in the assigned disease area under the instructions/support from his/her report line. Regulatory work level: Can analyze the risks and the business impact on his/her own department and other departments of regulatory and J-HA interaction strategies Required knowledge/skills Required Knowledge: Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work. Required Skills: Good communication skill, good presentation skills, good strategic thinking ability, good negotiation skills, good leadership skills, good problem-solving ability, good coaching skills both in English and Japanese, and OPA: 6.5 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 an inclusive culture, promoting diversity 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.