【ジョンソン・エンド・ジョンソン株式会社】[MedTech] Business Unit Regulatory Affairs Manager, Regulatory Affairs (CSS Group)
仕事内容
Key Responsibility
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.
応募資格(必須経験など)
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)