regulatory affairs manager：外資系大手製薬会社.

《外資系大手製薬会社にて薬事マネージャー募集！》Responsible for leading the team and encouraging changes and challenges, influencing stakeholders inside and outside the company, contributing to the achievement of organizational goals, enhancing performance and productivity, and fostering talent development regardless of whether there are direct reports.• Develop regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products (scope: new drug application, partial change application for new indication and/or new dosage and administration with clinical trial, new formulation regardless of clinical trial),• Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD,• Lead the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any type of responses document to Health Authority questions with the stakeholders (Non- clinical, clinical, Medical, Pharmacovigilance, CMC etc.),• Ensure maintenance and compliance of regulatory activities for development and marketed products,• Accountable for defining the project strategy and associated timeline, identify the risk and mitigation as the JAPC representative on GRT.• Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy.• Lead Japanese Package Insert Revision activities on Commercial and Medical Division’s request that is covered by PMDA New Drug Review Division.

求められる経験
【必須】
・薬事実務担当者として2年以上の経験

保険
労災保険

待遇・福利厚生
各種社会保険完備、社宅制度、退職金制度、財形貯蓄制度、共済会　等

休日休暇
日曜日,土曜日,祝日
完全週休２日制（土・日）、祝日、年末年始（12/29～1/4）、フレキシブル休日、5/１、年次有給休暇、慶弔休暇 他

給与
年収700 ～ 1,300万円

賞与
-
雇用期間
期間の定めなし