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A Range of Possibilities

Regulatory Affairs Intern, CEPiA China Sales Zone

date posted 09/10/2019
contract type Part time
job id R2521605
location Shanghai, China

KEY ACCOUNTABILITIES:

  • Preparation of open part and scanning of Batch Manufacturing Record, Process Validation Report, etc. for translation company
  • Proofreading of translated version from supplier
  • Translation of non-critical administrative documents
  • Follow up evolution of regulatory information of the Zone, and inform RA manager and Zone director; support RA manager on the translation of new regulations.
  • Follow-up new or updated monographs in the Pharmacopoeias of the Zone (Pharmacopoeia evolution) and support the translation.
  • Archive existing dossiers and registration related documentation.
  • Share folder maintenance
  • Printing of dossier, stamping, CD-ROM preparation, express mailing, etc.

JOB-HOLDER ENTRY REQUIREMENTS:

Education:

  • Bachelor degree or above in Pharmacy, Chemistry/ Biochemistry.

Experience & Knowledge:

  • Understanding of drug manufacturing and analytics
  • Familiarity with China registration regulations/CTD dossier is preferred.
  • Chemical synthesis/QC analytical background is preferred

Core Competencies:

  • Good competence in English and Chinese, fluency in oral English preferable.
  • Good interpersonal communication skill and executive capability.
  • Efficiency and Independence.
  • Strong learning & research capability.
  • Good computer skill in MS WORD, EXCEL and POWERPOINT.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

Continue