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Regulatory Affairs Department:Government and Regulatory Affairs
Joy Type:FTE
Working Location:Shanghai or Beijing
Application
Job Application

Responsibilities

1、Regulatory strategy development and implement

  • Develop regulatory strategy and development plan in conjunction with key stakeholders, with integrated knowledge of project management, regulatory, business, intellectual property and other disciplines about drug development 
  • Identify trends and leverage knowledge and insights to create a competitive advantage for projects through drug development and brand innovation
  • Set up the registration plan in conjunction with key stakeholders, and ensure that each project of new and marketed products is operated within the set timeframes
  • Ensure the project is conducted to the high professional standards of quality, and in accordance with local and international regulatory agency requirements and Standard Operating Procedures
  • Drive issue Management

          Provide regulatory inputs to product development and life cycle management team on complex interrelated issues

          Challenge plan, processes, timeline, bottleneck, resource and prioritized issue and come with the solutions

 2、Develop strong relationship with HA and external stakeholders

  • Build-up good image through high professional standard of application, response to enquiries etc
  • Establish good relationships with regulatory authorities through regular contacts and sponsorship for academic initiatives
  • Interact with industrial groups to design better processes for agency/industry interaction

3、Shape the regulatory environment and provides scientific assessment and guidance to team and stakeholders

  • Evaluate the impact and anticipate the implications of important emerging guidance and political environment evolvement, and timely communicate to relevant stakeholders
  • Advise management and to advocate a course of actions concerning the impact of emerging regulatory laws/regulations/guidance on the pipeline and portfolio
  • Proactively influence external stakeholder or relevant guidance base on in-depth understanding of the science

4、Support RA Director to develop a highly reliable and professional profile and process

  • Introduce and sponsor newly processes and work flows to meet emerging regulatory requirements
  • Interact with industrial groups to design better processes for agency/industry interaction

Qualifications

1、Education

  • Bachelor or above in Pharmacy, Medical, Biology or related field

2、Experience

  • More than 8 years experiences in regulatory affairs
  • Experience in handling complex regulatory projects, various kinds of regulatory submissions/approvals and experiences in involving into the development projects are required
  • Experience in complex regulatory environment assessment
  • Cross-functional management skill

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