Regulatory Affairs Executive

6 months ago


Sungai Buloh, Malaysia Yanling Natural Hygiene Sdn Bhd Full time

**職責**:
1. 辦理產品註冊(傳統藥物/天然產品、保健品和OTC)。

2.與監理機關的聯絡和談判

3. 向客戶/同事提供有關法規的建議

4. 協調與規範性文件或提交資料的準備相關的工作。

5. 隨時了解監管立法和指南的變化。

6. 維護現有和新興法規、標準或指導文件的最新知識庫。

7. 根據監管機構的要求,準備或直接準備額外資訊或答复,例如上市後監督。

8. 依照監管機構的要求指導實驗室樣本的採集和製備

9. 根據需要準備或維護技術文件以獲得和維持產品批准。

10. 準備對客戶資訊請求的答复,例如產品資料或書面監管事務聲明。

11.建議更改公司程序以因應法規或變化的變化

12. 根據需要協調召回或市場撤回活動。

13. 需要研究支持產品聲明的科學或臨床論文。

14. 能夠密切注意細節,對科學問題有良好的閱讀理解能力。



  • Sungai Buloh, Malaysia Yanling Natural Hygiene Sdn Bhd Full time

    **Responsibilities**: 1. To handle product registration (Traditional Medicine / Natural Product, Health Supplement, & OTC). 2. Liaising and negotiating with regulatory authorities 3. Providing advises about regulations to customers / colleagues 4. Coordinate efforts associated with the preparation of regulatory documents or submissions. 5. Keeping up to...


  • Sungai Buloh, Malaysia WELFORD MANUFACTURING (M) SDN BHD Full time

    1. To handle US FDA applications for medical devices registration. 2. To communicate with the Medical Device Authority (MDA) and relevant medical device regulatory bodies (EU and US FDA) or authority bodies (national/international) on product registration and approval such as product CE marking, MDR 2017/745 and US FDA compliance requirements. 3....


  • Sungai Petani, Malaysia Ideal Healthcare Sdn Bhd Full time

    **Responsibilities of this role**: **Regulatory Activities**: ii) Stay updated about changes in regulatory requirements, guidelines, and industry best practices. **Regulatory Compliance**: i) Monitor and ensure ongoing compliance with all applicable regulations and guidelines to maintain necessary licenses, certifications, and approvals. **Quality Systems...


  • Sungai Petani, Malaysia Jabil Circuit Full time

    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 250,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design...

  • HR Executive

    6 months ago


    Sungai Buloh, Malaysia Talent Houz Consulting & Services Full time

    **About the Job** **Responsibilities**: - Independently handle HR-related tasks, with a focus on recruitment and selection processes. - Manage employee relations, performance evaluations, and personnel management. - Formulate and implement human resource management systems and policies. - Oversee the entire payroll process, ensuring accuracy and compliance...

  • R&d Executive

    6 months ago


    Sungai Buloh, Malaysia KUALA LUMPUR FRIED CHICKEN (M) SDN BHD Full time

    1. Assist the team to innovate and create new recipes and ideas, improving existing products and involves in cost-saving projects. 2. Execute and evaluate product benchmarking and product testing on a regular basis. 3. Conceptualize and execute ideations for sauces, further processed products and retort products in consideration of ideas and market...

  • R&d Executive

    6 months ago


    Sungai Buloh, Malaysia KUALA LUMPUR FRIED CHICKEN (M) SDN BHD Full time

    1. Assist the team to innovate and create new recipes and ideas, improving existing products and involves in cost-saving projects. 2. Execute and evaluate product benchmarking and product testing on a regular basis. 3. Conceptualize and execute ideations for sauces, further processed products and retort products in consideration of ideas and market...


  • Sungai Buloh, Malaysia AG Staffing Malaysia Full time

    **Accountabilities**: - Overall responsibility of Accounting and Finance operations including GL, AR, AP and Capex - Tax related matters, including SST, withholding tax payment, import tax and etc. - Ensure accounting transactions and flows are accurate and on time - Review analyses of accounts to determine compliance with company policy and statutory...

  • Payroll Executive

    6 months ago


    Sungai Buloh, Malaysia T2P Solutions Sdn Bhd Full time

    **FFM Berhad** **Onsite, Sg. Buloh, Selangor** **Job Summary** Ensures accurate and timely processing of payroll for employees responsible for, while complying with relevant legal and regulatory requirements. Works closely with the HR Team and other stakeholders to maintain employee payroll records, resolve payroll-related issues, and provide excellent...

  • Account Executive

    6 months ago


    Sungai Buloh, Malaysia SIN HING HUAT AUTOCARE SDN BHD Full time

    1. Full set of accounting for the company including managing account receivables/payable, intercompany transactions. 2. Maintain comprehensive reconciliation of transaction and balance between company entities. 3. Perform day to day accounting functions to ensure compliance with accounting standards, statutory and regulatory requirements. 4. Able to...

  • Account Executive

    6 months ago


    Sungai Buloh, Malaysia MBB Asia Sdn Bhd Full time

    1. Full set of accounting for the company including managing account receivables/payable, intercompany transactions. 2. Maintain comprehensive reconciliation of transaction and balance between company entities. 3. Perform day to day accounting functions to ensure compliance with accounting standards, statutory and regulatory requirements. 4. Able to...

  • Qms Assistant

    6 months ago


    Sungai Buloh, Malaysia PRO-LANDSCAPE STRUCTURE SDN BHD Full time

    **PRO-LANDSCAPE STRUCTURE SDN BHD **is an establishment manufacturing children playground has made its presence in becoming a dominant player in manufacturing locally and international market. Our commitment and our passion for excellence have made it possible to turn challenges into great opportunities. We invite dedicated, energetic and suitably qualified...

  • Shipment Executive

    6 months ago


    Sungai Buloh, Malaysia OMM Graphic Sdn Bhd Full time

    **Responsibilities**: - Customer Service and Order Processing all tasks related to export orders. - Liaise and coordinate with forwarders for all shipment and transport arrangement - To handle full spectrum of shipping documentation (bank LC, Commercial Invoice, Packing List, FMM certificate & etc) - Handled and arranged import shipments. - Liaise with FMM,...

  • Coordinator Executive

    6 months ago


    Sungai Buloh, Malaysia PERKASA SUMBER JAYA SDN BHD Full time

    **SCOPE** - To define the qualification, skills and ability, experience and personal quality to perform the job. **ROLE PURPOSE** - The role of the Senior Executive will be to she/he operates in the department efficiently and effectively and meeting all the necessary goals and objectives set for it. **ROLE RESPONSIBILITIES** 1. Responsible for processing...

  • Legal Executive

    6 months ago


    Sungai Buloh, Malaysia T2P Solutions Sdn Bhd Full time

    **FFM Berhad, Sg. Buloh, Selangor** Provide advice on broad range of legal matters related to the company’s multiple business operations. Day to day scope will include but not limited to commercial contracts drafting and negotiation, advise stakeholders on general corporate commercial matters, manage dispute/litigation matters (as and when they arise) and...

  • Payroll Exacutive

    6 months ago


    Sungai Buloh, Malaysia Aisling Group Full time

    **Job Summary** Ensures accurate and timely processing of payroll for employees responsible for, while complying with relevant legal and regulatory requirements. Works closely with the HR Team and other stakeholders to maintain employee payroll records, resolve payroll-related issues, and provide excellent customer service to...


  • Sungai Buloh, Malaysia Yanling Natural Hygiene Sdn Bhd Full time

    1. To involve in product development including product concept development and unique selling point identification and differentiation. 2. Conduct market research and competitive analysis on nutraceutical market trend and competitor data. 3. Manage current product portfolio and customer account, conduct customer surveys to assess demand, create awareness...

  • Event Manager

    6 months ago


    Sungai Buloh, Malaysia M Owners malaysia Full time

    Job Title: Event Manager - Automotive Events Location: Malaysia **Job Type**: Full-Time About M Owners Malaysia Sdn Bhd: M Owners Malaysia Sdn Bhd is a premier automotive organization, dedicated to uniting car enthusiasts and professionals through premium, engaging, and profitable events focused on the automotive sector. We specialize in organizing...


  • Sungai Buloh, Malaysia MATASIGHT Optometry Full time

    Clinical Leadership: - Lead and manage a team of optometrists, opticians, and supporting staff. - Provide guidance, training, and mentorship to enhance team performance and professional development. - Oversee the delivery of high-quality optometric services, ensuring adherence to best practices and standards. - Monitor clinical operations, optimize...

  • Sustainability Manager

    6 months ago


    Sungai Buloh, Malaysia T2P Solutions Sdn Bhd Full time

    FFM Berhad Sungai Buloh (on site) The **Sustainability Manager **for FFM is responsible for leading and coordinating sustainability initiatives to enhance environmental performance, social responsibility, and ethical practices across the organization's operations. This role is critical in driving sustainable business practices, fostering stakeholder...