Senior Regulatory Affairs Manager
Senior Regulatory Affairs Manager
苏州工业园区 | 无需经验
发布时间:2017-10-18 15:27:23 | 截止时间:2018-02-28
  • 医疗器械注册
  • 全职
  • 若干
  • Job Requirements:
    1. Work Experience
    - 10 years above working experience with the registration area for medical products.
    - Familiar and good understanding of regulations for registration
    - Familiar with test center for registration in China
    -Have at least 5 years working experience in chemical industry
    2. Personal Competencies
    - Idea and systematic minded
    - Ability to work under pressure
    - Analytical and conceptual thinking
    - Rapid perception
    - Good at communication and coordination
    3. Social Competencies
    - Respect and esteem
    - Service orientation
    - Integration and contribution in team
    - Readiness to cooperate, helpfulness
    4. Professional Competencies
    5. Language
    -Chinese(native speaker)

    Job Responsibility:
    1. Regulatory Planning
    a) Regulatory Strategy Development
    Development of the Implementation Plan to align with the business need.
    b) Process Management
    i) Handling the homologation (registration) of all products independently.
    ii)Ensure Quality Management System (QMS) is effectively established. Rresponsible for internal and external audit and provide regulatory consultant, identify and monitor compliance of business operation
    iii) As the project manager during the registration stage, make the strategic and competitive plans for the regulatory process, lead the whole project team to approach the key milestones according to the plan and manage the communication and escalation pathway in a consistent manner.
    iv) Coordinates the process with other functional members of the affiliate and HQ to ensure timely availability of required documents and samples, if appropriate.
    2. Submission and Approvals of New Products and Marketed Products Maintenance
    a), Manage all the activities including but not limited to prepare dossier, obtain the regulatory approval and support the bidding efficiently and timely.
    b), Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements including manufacturing or labelling (insert and packaging) variations, renewals, repackaging and deregistration.
    3. Regulatory Compliance
    Be proactive to identify potential compliance issues and take corrective actions plans.
    4. Lead the team and coach the subordinates
    5. Manage the Regulatory Customer Relations and aware of any Regulatory Environment Change.
    6. Proactively communicate with the business functions of the global regulatory status of new products and local regulatory trends that may impact the business.
    7. Other duties assigned by Managing Director.
  • 大专
  • 不限
  • 国有企业
  • 中介服务
  • 0-49
  • 苏州工业园区旺墩路168号市场大厦