苏州招聘

职位描述：
工作内容：
1. Demonstrates excellent knowledge of the product application, dossier preparation, approval process and regulations for China by obtaining timely product registrations and/or corresponding commercialization permits.
2. Effectively interacts and communicates by e-mail, fax, telephone and conference calls with manufacturers and other departments on an everyday basis with relation to product registrations and their maintenance.
3. Assist with the review of new raw ingredients and their respective technical attributes for regulatory acceptability. Assist with the review of new preliminary and concept formulas to determine ingredient & formula acceptability and appropriate product classification in China
4. Reviews printed components & artwork to ensure product compliance.
5. Support the team to prepare technical dossiers for individual products to be reviewed and evaluated by CFDA officials for product approval. Requests and prepares supporting technical and non-technical data from manufacturers, internet search engines, technical library and various departmental sources as and when required.
6. Initiates and drives changes for items (raw materials, formulas, printed components, SKU’s) through the database system. Responsible for confirming formula and label acceptability, as well as the receipt of necessary licenses, prior to requesting the release of product.
7. Manage the response to technical and regulatory inquiries or complaints that fall under the Product Challenges Policy. May serve as Herbalife’s representative with government officials for product-related issues that fall under the Product Challenges Policy
8. Work with Scientific Affairs, Worldwide Regulatory & Government Affairs and the regional licensing teams to complete scientific and regulatory review of proposed product claims for new and existing products
9. Review and approve conditional releases for individual Bill of Materials items and Deviations affecting the raw material, raw material supplier, formula or printed component.
10. Issue Regulatory Holds for products and product components where necessary
11. Responsible for adding and updating product & regulatory data in the database system. Assists with the validation of data for country of responsibility, for use in all reports and queries.
12. Maintains and renews existing licenses for all products in China.
13. Review information on future legislative changes from Worldwide Regulatory & Government Affairs to assess potential impact on formulas, labeling and licenses in affected markets. Communicate regulatory or legislative changes to regional licensing and Home Office teams
14 Coach, train, give guidance and suggest training for each staff member to promote the growth of each individual and the department as a whole.
15. Carries out all responsibilities in an honest, ethical and professional manner.

任职要求：
1. University Degree or above, major in food, nutrition, chemistry, pharmacy or pharmacology.
2. Have plant licensing and/or product registration experience in health Food or Pharmaceutical Company at least 6 years. And within which at least 2 years with supervisor or management experience.
3. Be familiar with health food regulation and national standard.
4. Be familiar with GMP for health food or pharmaceutical for powder, liquid and solid products.
5. Read and write English fluently.
6. Must be proficient in Microsoft Office Programs eg. Word, Excel, PowerPoint and Outlook
7. Good Communication Skill and teamwork. 举报 分享

苏州高级人才咨询有限公司。