天津招聘

Job Purpose and Key
With the establishment of the iTCM BU and its near term goal of in-licensing and developing clinical stage drug candidates for China market, there are an immediate need of a senior leader with extensive drug R&D experience in relevant areas to take responsibilities in the following:

? Manage clinical supply needs and develop commercial supply chain plan
? Develop GAP sourcing and control strategy and plans for all iTCM projects
? Identify and review potential natural product in-licensing candidates
? Provide regulatory support to iTCM
? Lead supply chain and regulatory due diligence efforts
? Establish effective working relationship with SFDA/CDE
? Interact and interface with GSK local and global Regulatory Affairs
? Support global regulatory submissions as needed
? Oversee the quality and compliance aspects of iTCM key vendors
? Work effectively with other technical functional lines and matrix project teams
Accountabilities:

? Ensure clinical supply needs for all iTCM projects
? Ensure proper planning and execution of GAP herb sourcing
? Ensure proper regulatory procedures in place and all projects supported in iTCM BU

? Ensure in-licensing candidates are of suitable regulatory status and clear pathway for development and registration in China

? Ensure proper conduct of supply chain and regulatory due diligence

? Ensure proper quality of regulatory submission documents

? Ensure timely communication and interaction with SFDA/CDE

? Ensure quality and compliance of key iTCM vendors

Complexity:
? degree of change & uncertainty; level of influencing required; degree of matrix working

- Supply Chain management and regulatory/compliance function for iTCM is unique and very critical. An experienced veteran with extensive experience and network of people in the industry is best suited for this highly challenging work
- The candidate needs to be very effective communicators, interacting with key stakeholders, regulators and other technical lines and matrix teams
Specialized Knowledge:
? breadth & depth across disciplines or functions; expertise in field required; separate by basic and preferred

1. Fluent in English and Mandarin (both verbal and written) required.
2. Advanced Pharmaceutical degree or equivalent.
3. In-depth knowledge and experience in drug development and registration in China (global experience is a plus)
4. 10 or more years of leadership role in regulatory affairs and supply chain management with multiple IND and/or NDA submissions, preferably including TCM products

Basic Requirements:
Must be non-comparative, objective and relevant. Critical/essential to accomplish the role

Preferred Requirements:
Relevant to the role, but not critical/essential
1. R&D experience in TCM or natural products for Rx or Cx
2. Direct IND and/or NDA writing experience
3. QA/compliance work experience

葛兰素史克制药(苏州)有限公司是由葛兰素史克集团在苏州工业园区独资建造的现代化医药生产基地，该项目注册资金为1亿3千5百万美元，是葛兰素史克集团目前在华投资最大的项目，同时也是目前国内最大规模的外商投资制药企业。