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Responsible for the Regulatory Affairs Activities of Teva Generic / new product portfolio of Oncology, MS. Responsible for project regulatory strategy setting and regulatory submission and maintenance activities, to ensure timely submissions / approval of responsible products and delivery of regulatory intelligence. The position requires in related RA knowledge, experience and understanding of China regulatory regulations.
Implement with China regulatory strategies, including regulatory risk assessments, and support for all development compounds (registration) and marketed products (life cycle management) in responsible TAs
Ensure the registration strategy flawless implemented for Gx and new drugs application sub, and approval, including local clinical trial permits applications, Int’l CTA, BE, import drug license applications
Prepare and compile regulatory dossiers for submission and ensure submission projects are on track and filed in a timely manner
Support China operations on relevant legislation, directives and regulations within China including OTC, Gx and Specialty business in responsible TAs
Work closely with internal partners to ensure compliance with internal process and external regulatory requirements
Establish & maintain good relationship with HA
At least University Degree in life science, medicine, pharmacy or material science
At least 5 years’ experience of regulatory affairs in the pharmaceutical industry
Good knowledge in registration and assessment of imported drugs and Gx, including good knowledge and experience for drug product life cycle management, registration QC test and etc
Good knowledge of regulatory and healthcare system in China
Strong English communication skills both written and oral in view of building effective stakeholder relationship
Excellent interpersonal skills, teamwork and collaboration
Understanding of local regulatory environment, key initiatives – specifically regulation change and trends
Innovative and creative, openness to change and ability to think out of box
Demonstrated project management ability
Results oriented, entrepreneurial and self-motivating
Commercial IT Cluster Lead APAC
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