JOB SUMMARY職位摘要

We are seeking a dedicated and detail-oriented Regulatory Affairs Intern/ Assistant to join our team. As a Regulatory Affairs Intern/ Assistant, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the registration and approval processes for our products. This position offers an excellent opportunity to contribute to the success of our company while gaining valuable experience in the regulatory affairs field.

我們正在尋找一位專業且細心的法規事務實習生/ 助理加入我們的團隊。法規事務實習生/ 助理，您將在確保符合法規要求以及支持我們產品的註冊和批准流程方面扮演關鍵角色。這個職位提供您在法規事務領域獲得寶貴的經驗，同時為我們公司的成功作出貢獻。

RESPONSIBILITIES / ACCOUNTABILITIES 主要職責

• Assist in monitoring and ensuring compliance with local and international regulatory requirements related to the production, labelling, and marketing of products.
• Support the preparation and submission of regulatory documents for product registrations, variations, and renewals, ensuring accuracy and adherence to regulatory guidelines.
• Maintain organized and up-to-date regulatory documentation, including product dossiers, technical files, and labeling information, ensuring accessibility and completeness.
• Liaise with internal teams, such as R&D, Quality Assurance, and Marketing, to gather necessary information and facilitate effective communication regarding regulatory requirements and changes.
• Assist in preparing and submitting regulatory filings, notifications, and responses to regulatory authorities within specified timelines.
• Support regulatory audits and inspections by maintaining documentation and providing requested information to regulatory authorities.
• Handle ad hoc tasks and assignments as required.

• 協助監督並確保符合產品生產、標籤和行銷相關的法規要求。
• 支援準備並提交產品註冊、變更和續訂的法規文件，確保準確性並合規。
• 維護有組織且最新的法規文件，包括產品檔案、技術文件和標籤資訊，確保易於存取且完整。
• 與內部團隊（如研發、品質保證和行銷）聯繫，收集必要資訊，促進有關法規要求和變更的有效溝通。
• 協助準備並按照指定的時間表提交法規申報、通知和回應給監管機構。
• 通過維護文件並向監管機構提供所需資訊，支援法規審核和檢查。
• 根據需要處理臨時任務和分派。

PROFESSIONAL QUALIFICATIONS / EXPERIENCE 專業資格/ 經驗

• Currently pursuing an undergraduate, postgraduate or take bachelor's degree in a relevant scientific field, such as Nutrition or Food Science or related disciplines. A master’s degree is a plus.
• Previous experience in regulatory affairs, preferably in the food, pharmaceutical, nutrition, or baby formula industry is a plus.
• Good knowledge on local food regulations
• Good organizational, communication, and interpersonal skills.
• Proficiency in MS Office applications especially excel skills.
• Fluent in spoken and written English and Chinese.
• Available for at least 3 days a week, and 5 days a week during the summer or winter vacation is a plus.

• 就讀相關科學領域的學士學位或是碩士學位，例如營養學或食品科學…等。碩士學位為佳。
• 具有法規事務方面的經驗為佳，像是在食品、製藥、營養或奶粉業。
• 對本地食品法規有良好的了解。
• 具備良好的組織、溝通和人際交往能力。
• 熟練使用MS Office應用程式特別是精通 excel 的使用。
• 流利的英文和中文口語和書面表達能力。
• 至少每週可提供3天的工作時間，暑假或寒假期間可提供每週5天的工作時間為佳。

詳細資訊及應徵方式：

https://www.1111.com.tw/job/113014252/