上海招聘

Job Purpose and Key Responsibilities:
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:

? Provide regulatory support to all iTCM projects
? Establish effective working relationship with SFDA/CDE
? Identify and review potential natural product in-licensing candidates
? Lead regulatory and compliance due diligence efforts
? 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 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 regulatory and compliance 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

- 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 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
2. Direct IND and/or NDA writing experience
3. QA/compliance work experience

葛兰素史克是最早在中国大规模投资研发领域的国际制药公司之一，通过与中国政府、学术机构和医疗专家保持密切的合作，致力于提高中国人民的健康水平。在进入中国的20多年间，我们在国内的药物研发和临床研究方面已投入了10亿元人民币。我们的目标是使中国成为葛兰素史克全球研发体系中一个重要的战略中心。