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| 部署・役職名 | Regulatory Publishing Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
SUMMARY Responsible for formatting and publishing electronic documents and building regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs ＆ JNDAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications （eg, FDA, EMA, PMDA, ICH, etc） JOB RESPONSIBILITIES: • Manages staff and/or vendors who electronically format, publish electronic documents and builds Regulatory submission deliverables. Ensures quality, accuracy, and submission－readiness per Regulatory agency guidance and specifications, and internal procedures. • Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications （eg, FDA, EMA, PMDA ICH, etc） • Provides guidance on good documentation and submission practices. • Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications. • Coordinate submission activities such as creating and managing submission table of contents （TOCs） and tracking submission deliverables. This also includes drafting cover letters for routine submissions and uploading submission documents to the regulatory submission document management system （RDMS）Responsible for ensuring consistency and standardization to regulatory submissions across programs. • Provides guidance to Reg Submission Management （Reg SM） team members and cross－functional groups to resolve issues related to submission schedules, documents readiness or other submission or regulatory－related requirements that could impact the timeliness or quality of submissions. • Liaises with Regulatory Publishing on publishing timelines and resourcing for major submissions and provides feedback to Regulatory Liaisons and Regulatory Project Management （Reg PM） on submission timelines and potential resource issues. • Provide training/mentoring to internal and external publishing staff. May assist and/or provide training to others on software tools used and educating authors on publishing policies and procedures. • Identify, assess, and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions. • Assume the role of subject matter expert for specific functions or processes, interacting and • mentoring both within the department and with external stakeholders. • Evaluate activities and business processes, identify areas in need of improvement and take the lead in investigating potential solutions or new ways of working. • Responsible for global regulatory submissions/dossiers. • Performs day－to－day activities and deliverables as it relates to publishing of submission－related • documents for agency submissions. • Performs review and validation of submissions documents to ensure compliance with FDA, EMA, PMDA and ICH guidelines and internal standards for submission through eCTD format. |
| 応募資格 |
【必須（MUST）】 Education• Bachelor’s Degree xperience • 8＋ years of pharmaceutical experience • Requires knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications （eg, FDA, EMA, PMDA, ICH, etc）. • Advanced knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 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 | 2024/07/08 |
| 求人番号 | 3683411 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です