High-level 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 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

Including scope of entire roles and responsibilities, business impact of the job on the end results, consequences of errors, degree of relationship with global team, geographic/cultural/stakeholder scope and degree of supervision/guidance received. Maximize organization/team/individual performance (Evaluation/coaching/motivation/work environment optimization), include factors in case of team/project management as a leader.



Perform following roles while receiving instruction/guidance from supervisors if necessary.

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