Senior RA Manager
Spring Professional
Taiwan
21天前

Responsibility

  • As a successful candidate you should represent Regulatory Affairs on project team to ensure all regulatory requirements are met throughout the product lifecycle procedure.
  • Coordinate and draft the preparation of regulatory submission and applications to TFDA.
  • You are in charge of the management and preparation of regulatory submission dossier Abbreviated New Drug Application (ANDA), drug license maintenance, and management of outsourcing regulatory consultancy firms and legally authorized representatives
  • Execute and lead the assigned project to ensure compliance with domestic directives as well as government regulations.
  • Handle toll manufacturing projects with related change in line with government requirements. Preparing or maintaining technical files as necessary in order to obtain and sustain ethical product approval.
  • Requirement and Skills :

  • As a successful candidate, at least has pharmacist license or degree in Medical / Science, you should be familiar with pharma field, and regulation experience at least 8+ years of RA in multinational Pharmaceuticals industry.
  • You are expect to speak fluently in English, with aggressive, independent personality, and willing to work under pressure, good in communication, coordination and interpersonal skill.

    For further job description, please do not be hesitate to contact me via mail or you can send me your update English CV.

    I will contact with you as soon as possible.

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