日系企業での薬事・品質保証マネージャー募集！Regulatory Affairs & Quality Assurance Manager (18371)【パソナ】

日系企業での薬事・品質保証マネージャー募集！Regulatory Affairs & Quality Assurance Manager (18371)

【Job ID】18371

【業務内容】

日系医療関連企業にて薬事・品質保証マネージャーを募集しております。

・Liaise with HQ in Japan and support for regulatory affairs of Singapore (Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registration in Singapore)
・Liaise with related parties in Asia Pacific to support for regulatory affairs in South East Asia, Oceania and South Asia (Prepare & submit product registration documentation & other relevant licences’ application and ensure submissions are complete, properly formatted, and comply with applicable regulatory requirements that lead to timely approval of new product registrations in South East Asia, Oceania and South Asia)
・Ensure timely submission, notify and update Health Science Authority (HSA) & any other related authorities of any change of particulars or documents related to product registration
・Maintain the knowledge and awareness of current applicable regulations and standards in South East Asia, Oceania and South Asia in the view of RA & Quality Assurance. Update information to HQ and any other related parties.
・Liaise with related parties for new product registration, renewals, amendments and in all regulatory related area
・Serve as the primary contact between the company and regulatory agency (HAS) and liaise with other related parties in South East Asia, Oceania and South Asia
・Serve as the primary contact for quality assurance in South East Asia, Oceania and South Asia such as in the situations when defects occur to the products and etc. Report to HQ and related parties including government agencies and create a system for improvement in cooperation with HQ
・Attend QA audits of manufacturing factories in Japan
・Any other related duties assigned

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パソナシンガポールジャパンデスク
EA Registration Number: R1109019
Email : japandsk@pasona.com.sg
URL : http://www.pasona.com.sg
Tel : (65) 6734-7300（日本語ホットライン）
　　(65) 6732-6933（代表）
Add : 1 Finlayson Green #09-02 Singapore 049246
EA License No:90C4069