Regulatory Affairs Manager or above 部门:Regulatory Affairs  工作类型:Full time, Employee
工作地点:Shanghai, China
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Overview:

Regulatory lead for CStone products, including IND/NDA submission, CDE/NIFDC follow-up, communication and etc.; Be accountable for CDE pre-meetings in preparation and implementation; Compliance with applicable policies, procedures and other regulations.


Responsibilities:


  • Regulatory inputs for IND/NDA strategy making.
  • Be accountable for IND/NDA preparation, submission and PFDA review.
  • Follow up with review/approval process and coordinate with internal function team to response promptly.
  • Be accountable for the implementation of registration planning and tracking.
  • Be accountable on achieving the target timeline of submission and approval.
  • Provide regulatory support to line functions.
  • Contribute to optimize RA operational procedures whenever is needed.
  • Ensure regulatory compliance for responsible documents and archiving.
  • Closely monitor regulatory development and report to department head timely.


Qualification:


  • Bachelor or higher degree in life science areas preferably in pharmacy, biology or medical science.
  • At least 5 years of RA working experience on IND/NDA submissions.
  • Familiar with registration regulations and tech guidance; Proficiency in the organization of the registration package and writing of summaries.
  • Familiar with the registration process and requirements.
  • Outstanding communication skills; Capable of working independently and proactively with high team spirit and good interpersonal relationship.
  • Good skill in English speaking and writing.