Teva Associate Manager Regulatory Affairs 

China, Guangdong Province, Guangzhou City 

672488348

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

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