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 猎头职位-----健字号保健品申报经理 |
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Peter_Yu
头衔: 海归上士
年龄: 51
加入时间: 2011/06/13
文章: 6
来自: 广州市方尔达人力资源有限公司
海归分: 1710
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作者：Peter_Yu 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
From Peter Yu
Position: Regulatory Affairs Manager, **** Health– China
Reports To: Global Regulatory Affairs Vice President
Direct Reports: None
Overall Function: The RA Manager provides regulatory support for KH China on existing and new products under development to ensure compliance with regulatory requirements. This individual is involved in developing and implementing regulatory strategies, and supporting national product registrations. Direct interaction with the PRC MOH and SFDA is a significant part of the job responsibility. The position will also be responsible for maintaining product registration approvals by ensuring compliance with local legal requirements and supplementing registration submissions as necessary in response to changes in regulatory requirements.
Major Responsibilities:
• Understand regulatory requirements and relevant government regulations for KH products, stay current on regulatory issues affecting KH products, and research necessary pathways to comply with regulations; some work may also involve managing outside legal counsel and consultants on projects where needed.
• Work with the KH global regulatory team and the KH Asia team in implementing the regulatory strategies necessary to achieve timely filing and approval of new and existing products for China based on business objectives. Products may include ingredient registrations with the MOH, as well as finished product registrations (assisting KH customers) with the SFDA.
• Research and report findings on regional regulations on food ingredients in China.
• Communicate regulatory pathways and testing requirements for successful regulatory submissions and existing products compliance in China and AP to the Global Regulatory Affairs VP.
• Work with the KH Regulatory Team and KH Asian Team toward the adoption of a daily recommended intake value for lutein in China.
• Develop good working relationships with regional regulatory agencies and network with other regulatory contacts, including regulatory staff for ****’s strategic partner, DSM Nutritional Products. Attend meetings concerning registration and legislation of food ingredients.
• Serve as the RA liaison in KH’s PIP process, research and develop regulatory plans in conjunction with new product development and product launches for China where needed.
• Provide regulatory guidance and direction in the design and execution of clinical studies (safety, human clinical to support claims) if needed for new product submissions.
• Respond to customers requests for regulatory documentation and certificates and generate .
• Develop appropriate documentation and certificates MSDS, product specification sheets and labels where needed with validation by Global Regulatory Affairs VP)
• Assist in the review or creation of product information including but limited to product specifications, formulas, labels, MSDS, marketing/sales literature, labeling and advertising materials for compliance, analyze and recommend appropriate changes consistent with PRC
• Update monthly KH RA monthly report for China, participate in weekly RA conference calls, KH/DSM annual marketing and technical committee meetings, and KH Asia meetings, as necessary.
Qualifications & Experience
• Advanced degree such as Master’s degree in a relevant science field, preferably in nutrition, biochemistry, pharmacy or comparable discipline, five years work experience in a regulatory or related position, preferably in the health food industry.
• Strong knowledge in food safety and functional benefits of food, with a good understanding of food and health food regulations in China. Understanding of food quality (e.g., good manufacturing practice requirements, good agricultural practices) preferred.
• Experience with regulatory requirements in other Asian Pacific countries of interest (Korea, Thailand, Taiwan, Malaysia, Indonesia) a plus.
• Experience in assembling ingredient and/or finished health food product registrations for submission to the MOH/SFDA, and in responding to requests for additional information to support registration approvals.
• Experience in reviewing and evaluating the scientific literature with a demonstrated ability to analyze and assemble scientific information from many sources.
• Experience in the design and execution of safety and clinical studies (e.g., good clinical practices).
• Excellent attention to detail required, rigorous, reliable, accountable, highly motivated, ability to work independently.
• Personable; good interactive skills dealing with customers on regulatory and related business issues.
• Needs to interact well in a team environment and possess excellent verbal, written and interpersonal communication skills.
• Creative problem solver with inquisitive attitude.
• Good technical writing and presentation skills.
• Ability to produce high-quality work products under short time lines and keep focus while working on multiple projects
• A high degree of ethics and professionalism is needed for this position
• Excellent PC skills required
• Some understanding of patents and intellectual property (trademarks, copyright) preferred
• Good English proficiency as defined in the ACTFL Proficiency Guidelines
作者：Peter_Yu 在 生化制药 发贴, 来自【海归网】 http://www.haiguinet.com
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 猎头职位-----健字号保健品申报经理 -- Peter_Yu - (5300 Byte) 2011-6-14 周二, 14:24 (1570 reads)
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