Regulatory Affairs Specialist

1 day ago

Singapore beBeeregulatory Full time

Job Title: Regulatory Manager, Asia Pacific

We are seeking a highly skilled and experienced Regulatory Manager to join our team in the Asia Pacific region. This is an exciting opportunity for a professional with a strong background in regulatory affairs to contribute to the success of our organization.

About the Role:

  • Main liaison personnel with Head Quarters and all Partners on Regulatory matters for Asia Pacific countries
  • Coordinate all queries, variations, submissions and registrations
  • Handles product issues or complaints as well as quality issues
  • Update of PDM (Product Data Management) records and Packaging records
  • Maintain past dossiers and attend to queries relating to approved dossiers and dossier information
  • Records of trademarks for APAC countries
  • Maintenance of GTIN (Global Trade Item Number) information for products marketed in APAC countries
  • Individual Case Safety Report (ICSR) monitoring, reporting & documentation for products marketed in Singapore
  • Recall procedures, execution & documentation for products marketed in Singapore
  • Coordination of recall procedures, execution & documentation for products marketed in APAC countries in accordance to local regulatory requirements
  • Quarterly reporting of weekly literature screening outcomes
  • Annual reconciliation of ICSRs (Individual Case Safety Report) for Singapore
  • Coordinate with partners to reconcile the ICSRs for their respective countries
  • Pharmacovigilance training
  • Main Local Safety Officer (LSO) in liaison with Pharmacovigilance Department in HQ
  • Submission of Product Quality Reports (PQRs) and Periodic Safety Update Reports in countries where it is legally required

Requirements:

  • Degree in Pharmacy, Biology, Chemistry, or a related field
  • 3-5 years of experience in regulatory affairs, preferably in herbal or pharmaceutical products
  • Good understanding of regional health regulations
  • Strong attention to detail and organizational skills

Benefits:

This role offers a challenging and rewarding career opportunity for a motivated and experienced professional. If you have the necessary skills and qualifications, we encourage you to apply.

Others:

Please note that this job description is not an exhaustive list of duties and responsibilities, which may change over time.

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