岗位职责：

1.As a CMC group leader, responsible for establishing a new CMC team and team management.

2.Collaborate with site technology section teams to provide CMC expertise strategy to ensure and/or enhance regulatory compliance with Health Authorities application requirements for China site drug products.

3.Serves as the regulatory CMC expert to project team for the solution of complex technical issues and organize CMC submission dossier preparation, define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement.

4.Work with site QA team on CMC change assessment for Post Marketed drug products，evaluates proposals for regulatory impact, advise the validation strategies and research/test strategies，discuss the submission strategies and timeline with RA team.

5.Responsible for specification, quality control testing and inspection for Post Marketed drug products; Provide technical input and facilitate the discussion between RA and QC teams.

6.Responsible for supporting Health Authority on-site inspection on CMC RA related matters.

7.Develop network with pharmaceutical industrial associations and participate in CMC initiatives and task forces.

资历要求：

1.Master’s degree or above, pharmacy, pharmacy and other related majors.

2.Required with More than 5 years of relevant experience with CMC regulatory and regulatory, or equivalent industry experience.

3.Excellent written and oral communication skills required in English; Proficient in Japanese is preferred.

4.Experience with CMC regulatory and regulatory, or equivalent industry experience. Understanding of scientific principles and regulatory requirements relevant to drug development and post-market support.

Proven ability to provide strategic regulatory guidance to drug development, registration, and post market support teams. Proven ability in cross-functional cooperation, alignment and ownership in problem solving.