苏州招聘

职位描述：
Responsibilities:
In charge Regulatory & Clinical Affairs department, including domestic and oversea.
Be responsible for contacting and communicating with international customers in time to catch up with all requirements from these customers and related counties
Establish operating budgets, monitor the cost, effectiveness, and reliability of regulatory and clinical affairs activities to optimize resources, priorities spending, and ensure that targets and standards are met.
Set up registration plan for the responsible project, take leader for preparation and submission of applications, renewals and variations to the relevant authorities, in a timely and accurate manner. Follow up with regulatory authorities on submissions and regulatory issues
Participate in the compliance validation before the mass production for the registered product, including the product pattern, package size, package design etc
Provide project / study management for clinical trials consistent with applicable regulations, guidelines and policies
Understand regulatory requirements and relevant government regulations for products, stay current on regulatory issues affecting products, and research necessary pathways to comply with regulations
Work with the other team in implementing the regulatory strategies necessary to achieve timely filing and approval of new and existing products for China and Abroad based on business objectives
Communicate regulatory pathways and testing requirements for successful regulatory submissions and existing products compliance in China and Aboard
Prepare material for product register according to government laws and regulations
Provide regularly updated training internally
Provide the information of related law or regulation and advice to company’s management when needed

Requirement:
Bachelor degree
More than 10 years in Medical device or Pharmaceutical industry
Equivalent position in Medical device or Pharmaceutical industry
Experience including international Regulatory Affairs is a plus
Good relationship with SFDA and affiliates.
Experienced in people management
Fluent in English 举报 分享

Sphere established in 1998 years.
Up to now, Sphere have a successful track recorder to our client which include 500 fortune company, successful position include senior management, technical engineering, research and development, marketing and sales etc.
Sphere won support and trust from our client depend on our high working effect.