南京招聘

职位描述：
Responsibilities：
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. May serve as Herbalife’s representative with government officials for product-related issues
8. Work with Scientific Affairs, Worldwide Regulatory & Government Affairs and Regulatory Affairs & Product Compliance 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 Regulatory Affairs & Product Compliance 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.

Qualifications：
1.University Degree or above, major in food, nutrition, chemistry, pharmacy or pharmacology.
2.Have product registration experience in Food or Pharmaceutical Company at least 6 years; and within which at least 2 years with supervisor or management experience.
3.Be familiar with food regulation or knew the regulation about medicine and pharmaceutical.
4.Be familiar with health food or pharmaceutical for powder, liquid and solid products.
5.Proficient in verbal & written English
6.Proficient in Microsoft Office Programs eg. Word, Excel, PowerPoint and Outlook
7.Good Communication Skills and a team player 举报 分享

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