Regional Regulatory Analyst
7 months ago
**工作目的(該職位的簡要概述,即該職位存在的原因)**
1. 管理、支援、監控並確保 Baerlocher Malaysia 營運/存在的市場中一致遵守標準和監管事宜;
2. 確保以適當的方式處理產品和材料管理(PMM),並根據任何特定的法規要求監控合規性;和
3. 根據需要,支持亞洲境內法人實體的區域和本地運營,涉及監管事宜。
**資格(該職位所需的最低資格)**
- 科學領域學士學位,最好是分析化學/化學/塑膠或聚合物技術/應用科學或相關科學學科
- 對法律有輕微背景/基本了解是一個額外的優勢
- 在任何相關專業機構註冊是一個額外的優勢
**經驗(該職位所需的最低年限和經驗類型)**
- 擁有至少 5 年從事法律、化學品監管、產品監管事務以及跨國公司製造環境環境或類似能力的嚴格監管產品行業相關暴露合規方面的工作經驗。
- 在多司法管轄區合規方面擁有豐富的知識和經驗,特別是在亞太國家的監管要求和與業務性質相關的 GHS 建構模組方面
- 對監管審批流程有深入的了解,能夠解釋標準並維護與亞太市場合規相關的聲明
- 在動態的、矩陣式的組織和模糊的環境中良好地工作
- 擅長同時運行多個項目,同時保持進度並按時完成任務
- 優秀的英語寫作和溝通能力。精通其他第三語言是一個額外的優勢
- 擁有 SAP 應用程式處理與管理經驗
**主要職責和責任(描述工作必須取得成果以實現其工作目的的核心領域)**
- 在Baerlocher 存在的國家(例如政府機構/當局/理事會、行業協會或行業代表)尋找並維持良好的監管管道關係,與監管合作夥伴合作,及時獲取有關所有監管事項的任何變更或修訂的最新信息,以維護利害關係人的利益公司。
- 參與準備業務以遵守各種產品法規的工作,提交監管註冊、通知和其他所需文件,以確保遵守相關機構規定的期限。
- 處理與亞太地區監管合規活動相關的項目、文書工作並保持良好的記錄,以便於檢索。
- 參與和參加會議,以追蹤立法更新、具有相關報告要求的監管法規、規則框架的變化以及監管環境的發展
- 參與、協助區域監管集群工作小組和 Baerlocher 集團公司跨職能團隊的成員並在合規策略、宣傳活動、配方和化學物質管理方面密切合作。
- 收集、監控和處理與材料和成品內容相關的監管輸入/標準更新,傳達對業務的潛在影響,並向內部所有相關方(即:銷售和行銷/產品開發/生產/供應鏈/安全)提供及時更新團隊等)確保產品規格符合不同國家要求的法規要求。
- 與 RRPS 合作進行安全資料表 (SDS) 活動以及與產品和材料註冊、監管變更、更新要求履行相關的合規查詢,監控和維護記錄可用性和相關程序,以便於參考/檢索。
- 根據需要支援和協助當地營運活動,並管理與產品和材料相關的業務流程所需的合規文件驗證聲明的相互協調。
- 協助執行貿易管制(PHAN、FERT 和 ROH 的註冊、修訂和停用)、化學品監管、產品安全相關活動,並透過 SAP 模組確保合規性
- 評估和分析系統的產品監管數據,並維護最新的原材料資料庫作為履行合規/義務的監控工具,包括監管備案和文件活動的存檔。
- 準備和更新監管活動和化學物質管理報告,並每週/每月維護記錄,包括所有相關範圍/區域覆蓋範圍。
- 執行上級不時委託的其他職責
**能力(該職位所需的關鍵能力和技能)**
**1. 功能性(技能和知識)**
- 撰寫報告時要特別注意細節和截止日期
- 精通所有 Microsoft Office 功能
- 熟悉法律語言
- 重點專案管理基礎雄厚
- 出色的組織能力和能力,能夠在快節奏和以截止日期為導向的環境中持續滿足關鍵的截止日期。可能需要一些旅行
- 分析測試和協議方面的專業知識是額外的優勢
**2. 行為-核心與領導力**
- 創新、創造力和品質
- 驅動力與主動性
- 人際溝通
- 客戶導向
- 方向
**內部/外部關係**
- 與內部或外部各方密切合作,即:政府機構/理事會事務、產業協會、專業機構等。
- 與跨文化的跨職能/法律實體團隊互動,與監管夥伴合作
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