Regulatory Affairs Manager

主要职责:

• Support and implement registration strategy and plan for new product in China.
• Responsible for the applications and approvals for New Products within relevant therapeutic areas, variations of marketed products and license renewals within the set timeframe.
• Provide regulatory expertise to support company business.
• Conduct in compliance with local regulatory agency requirements as well as relevant companypolicy and internal SOP.
• Responsible for coaching and developing subordinates.
• Manage registration submissions for license renewal and variations to marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
• Keep the RA Head informed of the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.
• Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.

 能力要求:

• Bachelor degree or above in pharmacy or related science with a pharmaceutical major;
• Over 3 years experience in pharmaceutical product registration;
• Good knowledge of SFDA regulations and guidelines;          
• Good English skill both in spoken and written;                              
• Good communication skill.