募集要項

仕事内容: バイエル薬品株式会社での募集です。
ＣＭＣ薬事のご経験のある方は歓迎です。
●Lead regulatory CMC activities including Partial Amendment Applications （PAA） preapproval GMP/QMS inspections Foreign Manufacturer Accreditation/Registration （FMA/FMR） Marketing Authorization （MA） Notifications and Minor Change Notifications （MCN） .
●Prepare and review submission documents for assigned products including NDA/PAA/MCN ensuring alignment with customer needs and regulatory requirements.
●Independently assess Japan specific CMC regulatory risks develop feasible regulatory options and mitigation plans and recommend an appropriate strategy for assigned products.
●Engage in effective communication and/or negotiation with global functions product supply external supplier and health authorities to secure approvals for assigned products. Build trust and foster open dialogue and collaborative problem solving.
●Support the development of less experienced colleagues by providing guidance on regulatory processes change assessments and CMC regulatory stra…

応募資格

必須: 【学歴・資格】
●University degree or above

【経験・職務に必要な能力】
●3+ years of experience in areas of regulatory CMC and change management of marketed products
●Strong understanding of differences between Japanese and global regulatory requirements and processes related to CMC submissions including familiarity with health authority interactions
●Hands on experience assessing and implementing a range of post approval CMC changes
●Proven experience of CMC documentation for submission with excellent working knowledge of current electronic authoring document management and electronic regulatory submissions
●Solid technical background knowledge and understanding in at least one CMC technical discipline e.g. chemistry formulation analytical science or quality assurance
●A…

フィットする人物像: JAC Recruitmentでは、担当コンサルタントが直接企業へ訪問。だからお伝えできることがあります。
面談の際に、採用担当者からお聞きした情報やコンサルタント自身が感じた選考のポイントを皆さまへお届けします。

休日休暇: 【有給休暇】有給休暇は入社時から付与されます
初年度 10日 1か月目から
【休日】完全週休二日制
土
日
祝日
夏季休暇
年末年始
【有給休暇】
1～3月入社は20日。4月～6月入社は15日。7月～9月入社は10日。10月～12月入社は5日間

その他、赴任休暇、慶弔休暇、生理休暇、つわり休暇、産前産後休暇、育児休暇、私傷病休暇、公傷病休暇、公務休暇、罹災休暇、子の看護休暇、永年勤続休暇、ドナー休暇、介護休暇、ワークライフバランス休暇（年1日、社員が任意に設定）など

会社概要