Regulatory Executive - Singapore - PHARM-D SINGAPORE PRIVATE LIMITED

PHARM-D SINGAPORE PRIVATE LIMITED
PHARM-D SINGAPORE PRIVATE LIMITED
Verified Company
Singapore

4 weeks ago

Wei Jie

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Wei Jie

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Description

Job Description:


  • Technical enquiry support for unregistered products evaluation.
  • Pharmacovigilance responsible personPBRER, RM, recall
  • 2nd Checker on hospital evaluation/cold chain mapping
  • 2nd checker for Package inserts translation (Japan/Korea language)
  • Review of Controlled Drug recording/annual report submission
  • Prepare, review, and submit dossiers to regulatory authorities for registration of therapeutic products/medical devices
  • Attend to queries posted by regulatory authorities in a timely manner
  • Ensure company's product comply with regulatory requirements
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Attend to Post-Market Surveillance Activities/Request from regulatory authorities especially for pharma
  • Perform GDP, GDPMD, and GVP internal/external audits
  • Liaison with HAS for pharmacovigilance/audit.
  • QA release to ensure compliance of product labels and COA by performing checking prior to release in the market
  • Dear Healthcare, Professional letter for RMP/Product launch/Product recall
  • Approval on labelling amendments
  • Review labeling and marketing materials to ensure compliance with the relevant regulatory requirements
  • Review of marketing campaign and material to ensure compliance to Advertisement Act.
  • Review of agency technical agreement involving regulatory affair.
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