Regulatory Affairs Manager @ Global Pharma Company
Direct Involvement in Products LaunchHiring Company Name Job ID291273 Job TypeFull-time LocationTokyo - 23 Wards, Minato-ku Train DescriptionHibiya Line, Kamiyacho Station SalaryNegotiable, based on experience Date RefreshedNovember 19th, 2011 08:50 Minimum Experience LevelOver 6 years Career LevelMid Career Minimum English LevelBusiness Level Minimum Japanese LevelNative Minimum Education LevelBachelor's Degree Visa StatusJapanese national or permission to work in Japan required
Purpose of the job:
Preparing strategies for the successful registration of Lundbeck products in JapanMaintaining Lundbeck regulatory affairs activities in Japan to ensure regulatory compliance in relation to clinical trials & IMP managementManagement of employees in Regulatory Affairs, Lundbeck JapanResponsibilities:
Develop and maintain a Regulatory Affairs function within Lundbeck Japan.Create strong regulatory strategy plans to enable Japanese regulatory approval & liaise with global teams for approvalPrepare and submit regulatory documents and conduct meetings with PMDA/MHLWMaintain regulatory compliance with respect to clinical trials & IMP managementBe liason for regulatory aspects of Lundbeck projects with partners in JapanDevelop Regulatory Affairs function to ensure readiness for Lundbecks first own submission in JapanProvide (or liaise with CRO) with respect to maintenance for Lundbeck or partners products on market in Japan (package inserts, drug master file etc.)Develop personnel in within Regulatory Affairs groupMaintain regulatory achieveKeep updated within area of responsibilityAim at a good working environment in the organization-----------------------------------------------------------------------------------------------------------------
Focus on the central nervous system
From trading company to pharmaceutical niche company
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Focus on the central nervous system
From trading company to pharmaceutical niche company
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We are a research-based company. We engage in research to find new drugs for treatment of CNS disorders, including depression, schizophrenia, Alzheimer’s disease, Parkinson’s disease and insomnia.
These are serious disorders. They affect not only patients, but also their families and friends. Besides the stress of having a CNS disorder, patients are often exposed to prejudice because, in many sections of society, there is still far too little understanding of how adversely a CNS disorder affects an individual’s life.
We have taken upon ourselves the task of improving quality of life for persons with a psychiatric or neurological disorder, and we are working intensely to find and develop new and improved drugs. We believe that we can make a significant difference, and we are happy to do so in cooperation with others.
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