杭州招聘

  Associate Manager, Regulatory Affairs

1.      Screening various sources for relevant therapeutic area-related regulatory developments and information on regulatory-related competitor activities.

2.      Appropriately communicate the information and its potential impact within GRA and to other relevant functions within the company.

3.      Coordinate and guide review of relevant draft guidelines by functions and / or Global Regulatory Affairs including coordination of review of the generated company positions.

4.      Ensure that alignment on one position is obtained between all affected functions and regions.

5.      Maintain an effective Regulatory Intelligence database, providing Regulatory Intelligence services for development projects and for marketed products regarding regulatory requirements and external regulatory experts to allow GRA functions to anticipate and effectively implement new regulatory compliance obligations.

6.      Assist Regulatory manager for implementing and delivering regulatory submission and approval, and maintenance for new products/post-marketing projects within agreed timeline. Ensure regulatory compliance with government policy and company required SOPs.

7.      Establish and maintain close relationship with NMPA/ CDE/ NIFDC and other appropriate regulatory agencies and under manager’s guidance have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to NMPA. Establish relationship with HA and collaborate with key stakeholders in the local, regional and global organization.

Maintain good knowledge in general/product specific scientific and regulatory requirement/ process. Take the responsible for implementation of policy intelligence management as conducted by manager, to ensure local and global team is well informed with the regulatory update and maintain strong working relationship and communications with cross-functions to provide regulatory and policy information to support development strategy.

要求：

 1.    Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred. 

 2.    Minimum of 3 years’ experience in a multinational pharmaceutical company is preferred. 

 3  Strong oral & written communication skill; ability to work under pressure. 

 4.    In-depth knowledge of regulatory environment, regulations and guidelines. 

 5.      Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.         

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