Expoint - all jobs in one place

מציאת משרת הייטק בחברות הטובות ביותר מעולם לא הייתה קלה יותר

Limitless High-tech career opportunities - Expoint

Teva Associate Manager Regulatory Affairs 
China, Guangdong Province, Guangzhou City 
672488348

25.06.2024

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.

How you’ll spend your day
  • 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

Your experience and qualifications
  • 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

Reports To

Commercial IT Cluster Lead APAC

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.