求人を保存 検索に戻る 職務内容 求人情報 類似した求人Be part of one of the top Regulatory/Quality Healthcare Consulting CompaniesTake lead in the CMC RA department for the company for various projects企業情報Global Regulatory/Quality consulting company specialising in the pharmaceutical, medical device, cosmetic areasRich project pipeline working with some of the top health care companies in the industry to support in regulatory and quality activitiesJapan business grew exponentially within the past 5 years due to demandFully remoteInternational environment with extensive global collaboration職務内容Take lead in RA CMC strategy for company client's for various projectsLead the CMC RA departmentDevelop CMC RA planning in terms of any change control activities, submissions, communication with the local health authorities (PMDA, MHLW) etc.Lead proper registration for client's facilties for FMAExecute regulatory strategies to align client's strategiesPrepare in CTD documents to support in JNDA applications as well as any post-marketing activities理想の人材University degree in scientific or related fieldHigh fluency in English and Japanese (non-native level speakers will not be selected)CMC RA experience in the pharmaceutical industry with track record of product approvalStrong understanding of local regulations CTD requirementsAbility to communicate with local health authorities as well as with global stakeholder/clientsPeople management experience条件・待遇Competitive salaries and benefitsGreat work life balanceFully remote optionAmazing career progression in CMC RAWork with industry leaders who are solving various unmet medical needsInternational working environmentコンタクトZach Itozu求人番号JN-032025-6693010電話+813 6832 8683求人情報分野ライフサイエンス職種薬事・学術業界ヘルスケア・製薬勤務地東京23区雇用形態正社員担当コンサルタントZach Itozu担当コンサルタントの電話番号+813 6832 8683求人番号JN-032025-6693010企業タイプ外資系企業
