Regulatory Affairs Manager
杰能科(中国)生物工程有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2012-11-13
- 工作地点:上海-长宁区
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语精通
- 职位类别:法务经理
职位描述
We are currently seeking an outstanding individual to join our Regulatory Team in Asia Pacific. Location: China (Shanghai / Beijing) or Japan.
The primary responsibilities for this position include:
Manage regulatory clearance and/or compliance of enzyme products derived from GM microorganisms used in food processing and animal nutrition, and serve as focal point for information on same
Monitor GMO regulations, evaluate regulatory implications of product and process changes, and recommend compliance actions.
Answer regulatory questions from customers (internal and external)
Interact with regulatory agencies and trade associations on defined areas of responsibility/expertise
Represent department on project or product development teams, and in regional business meetings
May manage/supervise junior staff
Other duties, as assigned.
Requirements:
BS/MS in life sciences or related field and 5-8 years experience in biotechnology / regulatory affairs or related areas or PhD with 1-2 years experience.
Knowledge of regulatory requirements to gain approval of GMO products in main markets in Asia Pacific. General knowledge of scientific methods in R&D and Quality
Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents (e.g., technical reports/scientific papers).
Consistent proactive & interpreting attitude towards clients' issues and track record of strong team player.
Excellent skills in influencing and supporting others
Abstract conceptualization, problem solving, and critical thinking skills
Excellent planning, organizational and communication skills.
Ability to function in multidisciplinary and virtual environment.
Ability to stay focused working in independent working environment
Ability to interpret guidelines and regulations applicable to DuPont IB products.
Ability to communicate in English (verbally and in writing), Japanese, and/or Chinese. Competency in computer/software tools needed for job.
The primary responsibilities for this position include:
Manage regulatory clearance and/or compliance of enzyme products derived from GM microorganisms used in food processing and animal nutrition, and serve as focal point for information on same
Monitor GMO regulations, evaluate regulatory implications of product and process changes, and recommend compliance actions.
Answer regulatory questions from customers (internal and external)
Interact with regulatory agencies and trade associations on defined areas of responsibility/expertise
Represent department on project or product development teams, and in regional business meetings
May manage/supervise junior staff
Other duties, as assigned.
Requirements:
BS/MS in life sciences or related field and 5-8 years experience in biotechnology / regulatory affairs or related areas or PhD with 1-2 years experience.
Knowledge of regulatory requirements to gain approval of GMO products in main markets in Asia Pacific. General knowledge of scientific methods in R&D and Quality
Experience in preparing clear, accurate regulatory submissions/dossiers or similar documents (e.g., technical reports/scientific papers).
Consistent proactive & interpreting attitude towards clients' issues and track record of strong team player.
Excellent skills in influencing and supporting others
Abstract conceptualization, problem solving, and critical thinking skills
Excellent planning, organizational and communication skills.
Ability to function in multidisciplinary and virtual environment.
Ability to stay focused working in independent working environment
Ability to interpret guidelines and regulations applicable to DuPont IB products.
Ability to communicate in English (verbally and in writing), Japanese, and/or Chinese. Competency in computer/software tools needed for job.
公司介绍
杰能科隶属杜邦工业生物科学(IB)事业部,是一家工业生物技术行业领先的公司,开发创新酶制剂和生物产品,不断提高性能并减少洗涤行业、纺织行业、燃料和化学品行业对环境的影响。杰能科的历史可以追溯到1982年,有近2000名员工,并在全世界拥有13个生产基地。杰能科(中国)生物工程有限公司是由杰能科在华投资的独资企业,是杰能科在中国以及亚洲市场主要的生产基地及销售中心。同时,杰能科在上海拥有世界一流的研发中心。如果您已经准备好加入一个富有激情,开拓进取的团队,杰能科欢迎您应聘我们的职位。
如需了解有关杰能科的详细信息,请访问我们的网站www.genencor.com(英文网站)或www.genencor.cn (中文网站)。
DuPont Industrial Biosciences (IB) is combined by Genencor Business and DuPont Applied Biosciences Business, which is comprised of more than 2500 dedicated colleagues globally with $0.9 billion sales in 2010. We discover and develop market-based biotechnology solutions at 8 R&D sites, produce a broad portfolio of products and manage 19 operations sites worldwide.
This Business Unit is dedicating to developing customer-driven solutions that enhance value creation, reduce environmental footprints, and improve health & wellness for end user. IB is focusing on the business growth through bioprocessing technologies which build Genencor’s expertise in designing and operating cell factories, leverage Pioneer’s knowledge of crop science and relationship with growers, and apply DuPont’s capabilities in engineering and advanced materials. We provide animal science and solutions to improve the sustainability and efficiency of meat, fish and egg production; as well as enzyme solutions that reduce food production costs and extend freshness to feed the world. We offer products and technology for first generation ethanol and advanced biofuel production; materials and chemicals made from renewable resources to reduce dependence on fossil fuels. We promote solutions that improve product performance and process efficiency while reducing energy and water use; sustainable alternatives to less desirable chemical solutions to protect people and the environment.
IB business includes three Core Biobased Segments: Bioactives: enzymes, peptides and performance proteins for markets such as feed, food, cleaning, paper, personal care; Biomaterials: advanced materials made from renewable feedstocks used to make carpet, textiles and other products; Biorefineries: products and technology for converting agricultural feedstocks into carbohydrates and fuels. Besides, Cellulosic Ethanol and Biobutanol are enabling the growth of the Biofuel Industry for DuPont.
We aspire to be the leader to create world-changing solutions for a bio-based society.
如需了解有关杰能科的详细信息,请访问我们的网站www.genencor.com(英文网站)或www.genencor.cn (中文网站)。
DuPont Industrial Biosciences (IB) is combined by Genencor Business and DuPont Applied Biosciences Business, which is comprised of more than 2500 dedicated colleagues globally with $0.9 billion sales in 2010. We discover and develop market-based biotechnology solutions at 8 R&D sites, produce a broad portfolio of products and manage 19 operations sites worldwide.
This Business Unit is dedicating to developing customer-driven solutions that enhance value creation, reduce environmental footprints, and improve health & wellness for end user. IB is focusing on the business growth through bioprocessing technologies which build Genencor’s expertise in designing and operating cell factories, leverage Pioneer’s knowledge of crop science and relationship with growers, and apply DuPont’s capabilities in engineering and advanced materials. We provide animal science and solutions to improve the sustainability and efficiency of meat, fish and egg production; as well as enzyme solutions that reduce food production costs and extend freshness to feed the world. We offer products and technology for first generation ethanol and advanced biofuel production; materials and chemicals made from renewable resources to reduce dependence on fossil fuels. We promote solutions that improve product performance and process efficiency while reducing energy and water use; sustainable alternatives to less desirable chemical solutions to protect people and the environment.
IB business includes three Core Biobased Segments: Bioactives: enzymes, peptides and performance proteins for markets such as feed, food, cleaning, paper, personal care; Biomaterials: advanced materials made from renewable feedstocks used to make carpet, textiles and other products; Biorefineries: products and technology for converting agricultural feedstocks into carbohydrates and fuels. Besides, Cellulosic Ethanol and Biobutanol are enabling the growth of the Biofuel Industry for DuPont.
We aspire to be the leader to create world-changing solutions for a bio-based society.
联系方式
- 公司地址:上班地址:无锡