RA Manager
Spring Professional
Taiwan
12天前

Responsibilities

  • Participate in all activities related to regulatory affairs to support registration in Taiwan markets.
  • Responsible to compile and submission of dossier for new products according to local requirements for registration in Taiwan.
  • Prepare appropriate documentation for renewing licenses in Taiwan markets.
  • Prepare amendment and notification submissions in compliance with application regulations (Change Control).
  • Prepare in the development and implementation of regulatory strategies and update strategies based upon regulatory changes.
  • Liaise with external parties and cross-function teams to obtain information and documents for regulatory submission.
  • To maintain current knowledge base of existing and emerging regulations standards, or guidance documents in order to update company on new regulations / new procedures.
  • Keeping up-to-date with changes in regulatory legislation.
  • Education and Experience

  • Bachelor’s Degree in Science, Pharmacy, Chemistry or relevant disciplines
  • At least 8+ years of relevant experiences in Regulatory Affairs area of Pharmaceutical or Medical Device industry
  • Prior experience with the Medical Device Regulations and Common Submission Dossiers Template (CSDT) is added advantage
  • Quality orientation and high attention to detail
  • Excellent interpersonal and communication skills
  • Self-motivated and able to work independently with minimal supervision
  • Ability to adapt in a fast-paced setting with evolving goals and objectives
  • Fluent in written and spoken English
  • Minimal travel as required
  • Contact Details : randy.chen springasia.com

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