Senior /Regulatory Specialist, (CTGTP - Post-market Vigilance & Safety Monitoring)
HEALTH SCIENCES AUTHORITY
Healthcare / Pharmaceutical, Public / Civil Service
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.
- 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