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管理追踪各國醫療法規與公司產品適用法規確認,ISO13485品質管理系統文件維護,並協助內外部稽核
As the Post-Approval Studies Manager, you'll lead our client's efforts in overseeing and driving the success of post-approval studies, ensuring compliance, high-quality data, and effective stakeholder collaboration. The role will have the opportunity to understand what's it like to post market for meds.
The Regulatory Affairs Department obtains and maintains marketing approvals of responsible products in Taiwan. It ensures full local regulatory and company compliance and provides regulatory expertise to support clinical research, product launches, and business development so as to assist in achieving business growth and full compliance with legal requirements for pharmacovigilance regarding regulatory affairs' relevant responsibilities.
responsible for building up the Taiwan RA foundation
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