Senior /Regulatory Specialist, (CTGTP - Post-market Vigilance & Safety Monitoring)

HEALTH SCIENCES AUTHORITY
  • Job Category
    Healthcare / Pharmaceutical, Public / Civil Service
  • Contract type
    Full Time

Job Description

Responsibilities

Post-market vigilance and safety monitoring to ensure the continued safety of marketed CTGTPs, including instituting timely and appropriate regulatory actions to ensure the safe and appropriate use of CTGTPs.

 

  • Review and follow-up of safety signals relating to CTGTP products, and recommend regulatory actions and/or risk mitigation plans to address safety concerns.
  • Review and manage adverse event reports relating to CTGTP products and recommend appropriate follow up and/or regulatory actions.
  • Review and manage product defect reports and product recalls relating to CTGTP products
  • Conduct compliance checks, evaluate and follow-up of non- compliant cases relating to CTGTP products to ensure compliance to regulatory requirements.
  • Review and management of advertisement and sales promotion of CTGTPs for conformance to current regulatory requirements.

Requirements

  • Possess knowledge in related scientific disciplines, e.g., pharmacy, pharmacology, toxicology, medicine
  • Minimum 3 – 5 years of relevant regulatory experience or work experience in hospital or health-related fields
  • Relevant experience and knowledge in the field of cell, tissue & gene therapy products (CTGTPs) such as knowledge in cell culture techniques, molecular biology, flow cytometry, recombinant technology and use of vectors, biomaterials or animal toxicology will be an advantage
  • Good understanding of pharmaceutical laws and current international regulatory landscape and developments in the field of CTGTP will be an advantage
  • Excellent communication and interpersonal skills
  • Able to work effectively with others with diverse backgrounds and with officers from other branches to foster a culture of collaboration
  • Highly motivated with strong desire to protect public health and safety

Remuneration shall commensurate with experience. Interested applicants, please apply online.


Closing on 22 Jun 2021