Regulatory & Technical Specialist
诗微仕(广州)健康产品贸易有限公司
- 公司规模:50-150人
- 公司性质:外资(非欧美)
- 公司行业:快速消费品(食品、饮料、化妆品)
职位信息
- 发布日期:2017-02-17
- 工作地点:广州-天河区
- 招聘人数:1人
- 工作经验:2年经验
- 职位月薪:8-10万/年
- 职位类别:合规主管/专员
职位描述
职位描述:
【Responsiblites】
- Product compliance / formulation review. Ensure regulatory compliance of products by conducting regulatory reviews of product formulations for compliance against China regulations.
- Regulatory advice and guidance (China). Keep up to date with China regulatory considerations and changes.
- Registration of products (Conventional food, health food and cosmetic). Development and maintenance of product dossiers for regulatory affairs and other departments and authorities as required.
- Marketing and advertising content review. Review the marketing and advertising contents based on regulatory point of view
- Product label review from regulatory prospective. Draft and review the Chinese product label as per China regulations
- Support other function or department with regulatory opinions. Work cross functionally, providing technical and regulatory advice across internal teams, including customer service, quality assurance, innovations, operations, digital and marketing team.
- Act as a stakeholder between the New Product Development / Innovation, manufacturing and marketing processes, providing key technical, scientific and regulatory input for product development and compliance ensuring timely product introduction to the market.
- Assist to develop and maintain product dossiers for regulatory affairs (i.e. tables of evidence, product specifications, CFDA submissions, etc.) and other departments and authorities as required.
- Support to work cross functionally, providing technical and regulatory assistance across internal teams, including Customer Service, Quality Assurance, NPD, Operations, Digital and Marketing teams.
- Ensure regulatory compliance of therapeutic and non-therapeutic products by conducting regulatory reviews of product formulations for compliance against various domestic (CFDA) and international regulations, relevant codes of practice and market requirements
- Assist the team to manage & draft accurate product information. Approval of product labelling for
regulatory and technical compliance including the Chinese label of conventional food and
health food.
- Contribute to the development, implementation and maintenance of regulatory standard operating procedures, work instructions and data management to ensure due diligence and sponsor obligations are maintained at all times.
- Act as a contact point for the CFDA/CIQ in conjunction with Biostime representation. Provide input into government consultations affecting the business.
- Assist product related complaints issued by regulatory bodies within a timely manner
consistent with Swisse quality and performance standards.
- Liaise with the Chinese industry bodies as required to support the business position and product range.
- Keep up to date with domestic and international regulatory considerations and changes.
- Assist in different projects as required by the business in conjunction with multiple other stakeholders both internal and external as required.
- Assist to Complete health food product registration and notification including the preparation and
submission of the dossier and the related supplementation documents.
- Follow up CFDA panel review opinions.
- Support to resolve complaints and troubleshoot for the legal, customer service and quality departments.
【Qualifications and Experience】
- Qualifications in complementary medicine, health and/or life sciences.
- Minimum of 2+ year experience in technical and regulatory affairs.
- A sound understanding of therapeutic, technical and regulatory requirements for complementary medicines and foods/food supplements is essential.
- Understanding of technical, regulatory and legal issues relating to product listing, registration and marketing.
- International, especially CFDA regulatory experience is considered an advantage.
- Established relationships with CFDA and other Chinese governing agency KOL’s and section leaders will be considered an advantage.
【Skills & Attributes】
- Effectively manage Internal and External Relationships.
- Strong bi-lingual communication & interpersonal skills (English/Mandarin)
- Ability to assess risk and provide risk based regulatory advice to the business.
- Apply critical thinking to complex regulatory environments, thinking outside the square to create market advantage.
- Strong attention to detail.
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【Responsiblites】
- Product compliance / formulation review. Ensure regulatory compliance of products by conducting regulatory reviews of product formulations for compliance against China regulations.
- Regulatory advice and guidance (China). Keep up to date with China regulatory considerations and changes.
- Registration of products (Conventional food, health food and cosmetic). Development and maintenance of product dossiers for regulatory affairs and other departments and authorities as required.
- Marketing and advertising content review. Review the marketing and advertising contents based on regulatory point of view
- Product label review from regulatory prospective. Draft and review the Chinese product label as per China regulations
- Support other function or department with regulatory opinions. Work cross functionally, providing technical and regulatory advice across internal teams, including customer service, quality assurance, innovations, operations, digital and marketing team.
- Act as a stakeholder between the New Product Development / Innovation, manufacturing and marketing processes, providing key technical, scientific and regulatory input for product development and compliance ensuring timely product introduction to the market.
- Assist to develop and maintain product dossiers for regulatory affairs (i.e. tables of evidence, product specifications, CFDA submissions, etc.) and other departments and authorities as required.
- Support to work cross functionally, providing technical and regulatory assistance across internal teams, including Customer Service, Quality Assurance, NPD, Operations, Digital and Marketing teams.
- Ensure regulatory compliance of therapeutic and non-therapeutic products by conducting regulatory reviews of product formulations for compliance against various domestic (CFDA) and international regulations, relevant codes of practice and market requirements
- Assist the team to manage & draft accurate product information. Approval of product labelling for
regulatory and technical compliance including the Chinese label of conventional food and
health food.
- Contribute to the development, implementation and maintenance of regulatory standard operating procedures, work instructions and data management to ensure due diligence and sponsor obligations are maintained at all times.
- Act as a contact point for the CFDA/CIQ in conjunction with Biostime representation. Provide input into government consultations affecting the business.
- Assist product related complaints issued by regulatory bodies within a timely manner
consistent with Swisse quality and performance standards.
- Liaise with the Chinese industry bodies as required to support the business position and product range.
- Keep up to date with domestic and international regulatory considerations and changes.
- Assist in different projects as required by the business in conjunction with multiple other stakeholders both internal and external as required.
- Assist to Complete health food product registration and notification including the preparation and
submission of the dossier and the related supplementation documents.
- Follow up CFDA panel review opinions.
- Support to resolve complaints and troubleshoot for the legal, customer service and quality departments.
【Qualifications and Experience】
- Qualifications in complementary medicine, health and/or life sciences.
- Minimum of 2+ year experience in technical and regulatory affairs.
- A sound understanding of therapeutic, technical and regulatory requirements for complementary medicines and foods/food supplements is essential.
- Understanding of technical, regulatory and legal issues relating to product listing, registration and marketing.
- International, especially CFDA regulatory experience is considered an advantage.
- Established relationships with CFDA and other Chinese governing agency KOL’s and section leaders will be considered an advantage.
【Skills & Attributes】
- Effectively manage Internal and External Relationships.
- Strong bi-lingual communication & interpersonal skills (English/Mandarin)
- Ability to assess risk and provide risk based regulatory advice to the business.
- Apply critical thinking to complex regulatory environments, thinking outside the square to create market advantage.
- Strong attention to detail.
职能类别: 合规主管/专员
公司介绍
Swisse讲述了一个澳洲式成功的故事。它始于1969年的墨尔本,创始人Kevin Ring在一个简陋的仓库中成立了这家公司。从一开始,公司的使命便融入了Swisse的DNA——一个让全世界所有人都生活得更健康、更幸福的梦想。
这个愿景正在变成现实。过去40余年,Swisse基于传统经验和科学研究,不遗余力地投入在优质选材和产品配方的研发上。
今天,Swisse的产品系列涵盖了畅销的复合维生素、膳食补充剂、乃至运动营养、护肤品和功能食品。目前,它在澳大利亚、新西兰、新加坡和英国有售,在之后五年,它的销售网络将拓宽至30个国家。
这个愿景正在变成现实。过去40余年,Swisse基于传统经验和科学研究,不遗余力地投入在优质选材和产品配方的研发上。
今天,Swisse的产品系列涵盖了畅销的复合维生素、膳食补充剂、乃至运动营养、护肤品和功能食品。目前,它在澳大利亚、新西兰、新加坡和英国有售,在之后五年,它的销售网络将拓宽至30个国家。
联系方式
- 公司地址:上班地址:广州市天河区珠江新城珠江西路5号广州国际金融中心29楼