社名
社名非公開
職種
薬事、メディカルライティング
業務内容
...
Roles & responsibilitiesPlay following roles and take responsibilities at each phase in the life cycle of the XXXX 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.
求められる経験
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
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収1,200 ～ 1,500万円
賞与
-
show more
社名
社名非公開
職種
薬事、メディカルライティング
業務内容
...
Roles & responsibilitiesPlay following roles and take responsibilities at each phase in the life cycle of the XXXX 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.
求められる経験
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
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収1,200 ～ 1,500万円
賞与
-
show more
