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Lead Regulatory Affairs Specialist （Project Leader）, Japan

年収：800万～ 1000万

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部署・役職名	Lead Regulatory Affairs Specialist （Project Leader）, Japan
職種	薬事
業種	電気・電子医療機器メーカー
勤務地	東京都
仕事内容	Position Overview: RA project leader is responsible for all RA tasks of own modality without detailed supervision by the direct manager. As a project leader, lead RA members to submit in time as necessary providing guidance from an experienced professional standpoint. Report to direct manager or to core-team co-workers about submission projects status when it’s requested. This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.　 Key Responsibilities: ・Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets. ・Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions. ・Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch. ・Assesses changes in existing products to and determines the need for new /revise licenses or registrations. Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries. ・Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements. ・Contributes to writing and editing technical documents. ・Assesses adverse events through approved license dossier to support Safety Management Team. Understands and applies regulatory requirements and their impacts for submissions. (Monitor new/revised　　requirements and investigate the impact to Japan registration. Triage entry and to be Subject Matter Expert as required. ・Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions (Access to multiple sources to get necessary information with clear objectives and strategies.) ・Ensures compliance with pre- and post-market product approval requirements. (Lead communication with authorities as necessary and take appropriate action without detailed supervision of direct manager.) Supports regulatory inspections as required. (Support direct manager to have internal and　external audit.) Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
応募資格	【必須（MUST）】 A min. of 5 years experiences to handle product registration project as an independent Regulatory Affairs professional. QA/Safety Management experience is also preferred. Advanced level Japanese language skill to understand regulatory documents and to generate high quality submission package. Business level English (writing, reading, speaking) is required. Proven interpersonal skills and ability to communicate effectively with regulators, colleagues and business partners. Professional judgment and ability to operate with some autonomy, seeking senior guidance when necessary. Flexibility to adapt to different & unique process and cultures in new working environment. Especially, sharing mind, coaching skills and motivation to contribute for team, are preferred.
アピールポイント	自社サービス・製品あり外資系企業女性管理職実績あり 20代管理職実績あり上場企業従業員数1000人以上創立30年以上年間休日120日以上産休・育休取得実績あり教育・研修制度充実シェアトップクラス
受動喫煙対策	その他「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」などの場合がその他となります。面接時に詳しい内容をご確認ください
更新日	2024/12/20
求人番号	4177824

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GEヘルスケア・ジャパン株式会社

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