メディカル>医薬品メーカー 会員属性などに応じ、当該求人をビズリーチ上で閲覧された際に内容が異なる場合があります Key Responsibilities:
Project Management for all project in the team. Make RA strategy for new product introduction to drive our business. Take action to inquiry and/or instruction from Health Authority as a representative from Business Unit Regulatory Affairs in J&JKK.
Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part Assist the group member as a first-line manager, to plan and evaluate performance.
Mentor, coach, train and develop the direct reports. Evaluate performance and provide opportunities for growth. Communicate with all stakeholders including commercial and OpCo related RA matters in the team.Contribute to RA organizational action as DRI or SME for assigned project Contributes to development of team budget and implements cost controls.
Education:
Bachelor's degree or an equivalent (or higher) is required Experience and Skills: Required: Experienced Class III/IV NPI related action (At least 5 years) RA knowledge and experiences People management experience (2 or more members) Work experience with global team Business level communication both in Japanese and English Demonstrates influence, negotiation and conflict resolution in matrix environment.
Rich experience in communication of regulatory requirements and regulatory issues.Nice to have:
Experience of Class III/IV NPI leveraging Clinical Study Report (CSR/CER) is highly regarded. (Not essential) Scientific background (e.g. Mechanical Engineering, Electrical Engineering, Biology, Chemical) 産休・育休取得実績あり 創立30年以上 従業員数1000人以上 女性管理職実績あり 教育・研修制度充実 管理職・マネージャー リモートワーク可