Senior/ Regulatory Consultant (Cell, Tissue and Gene Therapy Products)
HEALTH SCIENCES AUTHORITY
Healthcare / Pharmaceutical, Public / Civil Service
Work Location: Helios, 11 Biopolis Way, Singapore 138667
At HSA, we regulate innovative therapy health products including complex regenerative medicines. Cell, tissue and gene therapy products (CTGTPs) represent a promising new paradigm in therapeutics and have the potential to revolutionise treatment modalities. Current research and development in CTGTPs has highlighted the potential of many of such products moving through clinical trials into product registration.
We are looking for an experienced and qualified individual to join the Innovation Office and Clinical Trials Branch who can further build up the regulatory and scientific expertise of the HSA to effectively regulate CTGTPs.
The senior/regulatory consultant provides regulatory, scientific and technical leadership in the regulatory review of cell, tissue and gene therapy products (CTGTPs) to support the safe use of investigational CTGTPs in human clinical trials, and to support the development of CTGTPs for product registration in Singapore
- Provide regulatory leadership to drive the review, development and implementation of regulatory and legislative policies, scientific and technical standards, industry guidelines, and good practices for clinical trials of CTGTP (Cell, Tissue and Gene Therapy Products
- Environmental scanning with view to provide strategic and scientific inputs to ensure the regulatory framework is responsive to emerging developments
- Lead the review of complex first-in-human/early phase/emerging innovative CTGTP clinical trials
- Mentor junior officers on the analytical and scientific evaluation of CTGTP trials
- Drive capability building for emerging innovative CTGTP to ensure continued scientific excellence
- Lead regulatory and scientific discussions and advice to stakeholders on the efficient pre-clinical, quality and clinical development of CTGTPs, with view to support local product registration
- Represent HSA as a technical expert at regional and international meetings, to influence strategic directions and desired technical and scientific outcomes of interest
- Strengthen and enhance HSA’s credibility and regulatory standing
- Possess specialised knowledge or experience in relevant scientific disciplines, e.g., stem cell biology, genomics, immunology, tissue engineering, biomaterial science
- At least 6 years’ experience as a regulatory consultant or equivalent scope of work in cell, tissue and gene therapy products
- Demonstrates in-depth scientific knowledge of the CTGTP field, including the scientific advancement and developments in this space, and the ability to provide strong and effective professional and scientific leadership
- Demonstrates a high level of knowledge on the regulatory considerations in CTGTP regulation, and the regulatory frameworks in major overseas markets e.g. US, EU.
- Demonstrates high level of competence in strategy and policy development in CTGTPs
- Relevant experience in participating in international scientific advisory committees/workgroups for CTGTPs preferred
- Line management experience, and ability to mentor and train junior scientific officers
- Critical and strategic thinker with good analytical skills
- Good interpersonal, communication and supervisory skills
- Ability to communicate confidently and diplomatically with various stakeholders
- Ability to travel for overseas work assignments
Successful candidates will be offered contract employment. Remuneration shall commensurate with qualification and experience. Interested applicants, please apply online.
Closing on 22 Jun 2021