Regulatory Affairs Director

Careers

Regulatory Affairs Director

职位编号 Job Code: CNCMC01

职位 Position: Regulatory Affairs Director

部门 Department: Biologics CMC

汇报关系 Reports to: VP

办公地点 Location: Remote

 

职位目标 Purpose or Objective of Position:

Timely and accurately grasp the policy orientation and approval principles of drug regulatory authorities for product registration and application, formulate company registration response strategies, complete communication with drug regulatory authorities, review registration documents, coordinate with the project team to arrange the specific implementation steps of CMC registration, and promote the registration of varieties progress and completion.

 

主要职责 Key Responsibilities

  • According to the company’s project establishment and research and development plan, formulate the company’s product registration annual plan, and organize the implementation;
  • According to the requirements of product registration progress, organize, coordinate and supervise the work progress of various departments to ensure that the compilation of application materials is completed on time;
  • Guide the registrants to carry out the registration declaration of related varieties, and promote the registration progress of the declared varieties;
  • Responsible for the review of registration documents, timely propose solutions for key issues and key steps in registration application, and organize and coordinate relevant departments to solve them;
  • Timely and accurately grasp the policy orientation and approval principles of the drug regulatory department for product registration and application, and formulate the company’s registration response strategy;
  • Track competitive product information;
  • Assess compliance at all stages of drug development and production, and issue relevant action recommendations;
  • Responsible for arranging the on-site inspection of drug registration, and coordinating with the project manager and project team to answer the questions of the on-site inspectors to ensure the smooth passing of the on-site inspection;
  • Responsible for the daily contact and exchange of external regulatory departments and review agencies at all levels;
  • Responsible for CRO communication, coordination and management.
  • Responsible for communicating with the Quality Department to provide advice and guidance on supervision and compliance.

关键绩效指标KPI’s

The completion of annual registration indicators, the accuracy and timeliness of data review, and the smoothness of communication with regulatory authorities and review agencies at all levels.

 

职位要求Job Requirements:

Education:

Master’s degree or above, major in biology, pharmacy, pharmaceutical regulations and other related majors.

 

Experience:

  • More than 5 years of experience in domestic and foreign drug registration and application work in well-known enterprises in the same industry at home and abroad, and more than 3 years of team management experience;
  • Understand the basic process and key steps of biomacromolecular drug development and production;
  • Familiar with China’s CFDA (NMPA), FDA, EMA and Australia’s drug registration related regulations and actual application process;
  • Understand the technical guidelines of ICH and be able to use them skillfully;
  • Proficient in the writing of eCTD data;
  • Good bilingual ability in Chinese and English.
  • Strong sense of responsibility, serious and careful, and good team spirit.

 

直接下属Direct Reports:

NA

We offer our employees the opportunity to grow individually while working collaboratively to make a difference in the lives of the patients we seek to serve.