募集要項
- 仕事内容
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・Responsible for driving the submission globally for assigned products: approvals and renewals according to marketing needs, managing the preparation, content and format of the submissions
・Liaison with health Authorities and internal and external Experts, with country Regulatory Managers, interactions with the relevant manufacturing sites
・Responsible for driving clinical trial applications
・Providing data packages according to local requirements, Preparations of prescribing documents ( SPCs, Package inserts, labels)
・Preparing regulatory strategies and evaluating risk assessment. Evaluation and assessment of regulatory requirements for variations, extensions and New MAAs .
・Due diligence participation
・Providing advice on ICH/Intercon regulatory legislation, support intercom group
・Data entry (GRAB), document handling (REAL)
・Responsible for continuously development knowledge and finding innovative solutions to regulatory problems
・Monitoring and training of new regulatory staff
- 応募資格
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- 必須
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・ 5-10 years experience in Regulatory Affairs or equivalent
・ Perfect knowledge of current rules and procedures for product registration
・ Fluency in English and local language
・ Good computer skills
・ Good Negotiation skills
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 1200万円 ~ 1800万円