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新加坡商三得利健益亞太股份有限公司台灣分公司

RA Manager 法規遵循經理

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Description

1.法規遵循
-確保所有化妝品和食品符合國際市場的法規要求。
-保持更新全球化妝品食品法規和標準,並將變更傳達給相關利益相關者。

2.產品註冊與批准
-管理和監督新產品和現有產品的註冊和批准流程。
-與當地法規機構聯絡以確保及時的批准和市場進入。

3.標籤與文件
-審查和批准產品標籤和廣告以確保符合法規標準。
-根據需要準備並提交必要的文件給法規當局。

4.風險評估與管理
-進行與法規變更及對產品合規性潛在影響相關的風險評估。
-當法規風險上升時,決定影響的程度並連結至管理決策。
-開發和實施策略以減輕法規風險。

5.跨部門協作
-與研發、品質保證、行銷和其他部門密切合作,將法規要求整合到業務活動中。
-在產品開發和行銷活動期間提供法規指導。

6.利益相關者溝通
-作為內部和外部利益相關者的法規聯絡點。
-作為一名法規專業人士,始終努力獲取最新信息並保持高水平的知識。

7.團隊管理
支援高階經理進行法規/品保團隊的管理。

1. Regulatory Compliance

  • Ensure all cosmetics and food products meet the regulatory requirements of international markets.
  • Stay updated on global cosmetic food regulations and standards, and communicate changes to relevant stakeholders.

2. Product Registration and Approval

  • Manage and oversee the registration and approval processes for new and existing products.
  • Liaise with local regulatory agencies to ensure timely approval and market entry.

3. Labelling and Documentation Review and approve product labelling and advertising to ensure compliance with regulatory standards.

  • Prepare and submit necessary documents to regulatory authorities as required.

4. Risk Assessment and Management

  • Conduct risk assessments related to regulatory changes and potential impacts on product compliance.
  • When RA risks arise, determine the extent of the impact and link to management decisions.
  • Develop and implement strategies to mitigate regulatory risks.

5. Cross-Functional Collaboration

  • Work closely with R&D, Quality Assurance, Marketing, and other departments to integrate regulatory requirements into business activities.
  • Provide regulatory guidance during product development and marketing campaigns.

6. Stakeholder Communication

  • Serve as the regulatory point of contact for internal and external stakeholders. As a RA

professional, always strive to acquire the latest information and maintain a high level of knowledge.

7. Team Management - Support the Senior Manager in the management of the RA/QA team.

Skills

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See also