・Provide appropriate CMC regulatory strategy in each stage of development, approval review (JNDA/sJNDA), and life cycle management in order to achieve BMSKK business goal, and execute tasks according to this strategy.For that objective, obtain information from the inside/outside of BMSKK and understand the latest regulatory requirements. In addition, communicate appropriately with regulatory authorities (Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare).
・Take part in the development team and JNDA/sJNDA team. Propose CMC regulatory strategy by himself or herself, and execute tasks. Align with colleagues for not only task execution but also knowledge/skill acquisition.

■Roles & responsibilities
Fulfill his/her responsibilities in the stage of development, approval review (JNDA/sJNDA) and life cycle management while considering the instruction/guidance from supervisors/superiors based on his/her own judgement.
・Carry out risk assessment in each stage. As necessary, propose and implement risk management plan.
・Contribute to cross-functional team through having regulatory discussion from CMC regulatory aspects and providing appropriate information regarding the development strategy.
・Provide regulatory and technical advice to related parties including Global teams.
・Align with colleagues for not only task execution but also knowledge/skill acquisition.
・Support junior colleagues’ responsibilities.


■Development:
・Provide information needed for Clinical Trial Notification (CTN). If necessary, cooperate with global team and prepare CMC-related attached documents for CTN in consideration of submission timing.
・Provide information to Global team in order to develop pharmaceutical products that are acceptable in Japan.
・Evaluate the necessity of PMDA consultation for biologics based on outcomes of other countries in collaboration with Global team, if critical manufacturing process change is needed and/or development plan, which will impact products quality, is developed.
・Evaluate excipients from viewpoints of new excipients (precedence of excipients) and biological ingredients standard and share the information to relevant department if necessary.


■Approval review (JNDA/sJNDA):
・PMDA Consultation: Plan strategies and gain agreement through discussion with Global team in order to receive expected response. Prepare documents according to the strategies.
・CTD Preparation: Prepare CTD through discussion with Global team that the contents of CTD meet the regulatory requirements and are aligned with agreement with Global team.
・GMP/GCTP inspection: Provide the information on the manufacturing sites, etc. listed in the application form for marketing approval to the lead department, and provide support. In the on-site inspection, accompany as a member of the marketing authorization holder and support the inspection mainly from the viewpoint of the content of the application form for marketing approval.
・Communication with the authorities: Regarding the PMDA consultations and  approval review etc., submit responses prepared as outlined in the agreement of Global team through explanation on meaning of queries, discussion and negotiation for generation of the best responses. Plan to hold a F2F meeting with the authorities, if necessary.


■Life cycle management:
・Based on the information of change control initiated by manufacturing department, propose appropriate regulatory strategy and execute regulatory tasks in the point of view of product supply and the situation of Product Assurance and Marketing.
・Control approval timing of the partial change application based on the information of manufacturing department.
・If inquiries on commercial products arises from outside of BMS, take appropriate actions in cooperation with related parties (Medical information, etc.).
・Facilitate inquiries/support from the parties related the product quality (manufacturing department, GQP, etc.).
・Inform supervisor when negotiation with other parties is necessary in order to facilitate task related to the life cycle management.