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Regulatory Affairs Senior Consultant

• Ensures compliance with regulatory agency regulations and interpretations.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Involved with the preparation of necessary outlines, summaries, status reports, project reports, memos and slides. 
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches, collects data, and responds to requests from regulatory agencies and/or clients to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information internally and to clients.
• Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance with CFDA requirements.
• Provides regulatory guidance to product development teams and responds to product information requests.
  
• Performs GAP analysis of API and finished product dossier for the Chinese market.
• Leverages scientific and technical understanding of regulated products to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
  
• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with customers’ business objectives.
  
• Engages with local and/or regional regulatory agencies.
• Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances.

  
  

• Bachelor degree from accredited college or university in science, chemistry, biology, pharmaceutical biotechnology, pharmacy, medical / scientific writing.
• At least 7 years of regulatory affairs or related/equivalent experience.
  
• Experience with domestic regulatory submissions is required.
  
• Experience with or exposure to foreign regulatory submissions.
• Experience with Japanese regulatory submissions is a plus.
  

• English: Fluent (mandatory)
• Chinese: mothertongue
• Japanese : nice to have

Sales

• Education: Bachelor’s Degree
• Sales mentality: open-minded, people person, eager, enthusiasm, result orientated and team player
• Fluent English for communication with non-Chinese speaking team
• Full availability to travel domestically and internationally
• Able to work under pressure and stay resilient
• 学历: 本科
  
• 销售思维: 心胸开阔, 喜欢与人互动, 热心, 热情, 结果导向, 团队合作精神。
• 英语流利, 能与非中文团队沟通
• 能够接受国内和国际旅行
• 能够在压力下工作并保持弹性。

• Sales-related experience: 2 – 4 years of experiences preferably in B2B environment
  
• Main tasks may involve: Marketing, Sales and Business Development
• Support senior sales manager

• Able to coordinating, supporting and organizing conventions, seminars or workshop

• Preferable: working in western company culture, familiar with pharmaceutical industry

• 与销售相关的经验: 2-4 年的经验, 最好在 B2B 环境
  

• 主要任务可能包括: 市场营销、销售和业务发展
• 支援高级销售经理
• 能够协调、支持和组织公约、研讨会或讲习班
• 偏好: 在西方公司文化中工作, 熟悉医药行业语言

• Chinese: native
• English (B2/C1): mandatory
• 中文: 母语
• 英语 (B2/C1): 必须

• Salary negotiable;
• Sales commission based on the sales result;
• Social contribution and insurance with housing fund;
• Housing allowance (if applicable);
• Commercial insurance, health examination, commuting allowance etc.
• 薪资面议;
• 根据销售结果所得的销售奖金;
• 社会保险和住房基金保险;
• 住房津贴 (如果适用);
• 商业保险、体检、通勤津贴等。