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Senior/Regulatory Specialist

2 weeks ago

Singapore Health Sciences Authority Full time $90,000 - $120,000 per year
What you will be working on:
  • Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approvals to assure the quality of medicines supplied in Singapore
  • Provide advice / guidance on the regulatory requirements and procedures for therapeutic product regulatory submissions, and to respond to enquiries from industry and healthcare stakeholders as well as member of public
  • Participate in projects and process/regulatory reviews
What we are looking for:
  • Background in Molecular Biology, Biochemistry, Chemistry, Pharmacy or related disciplines.
  • Experienced in pharmaceutical manufacturing and quality control of biologics and / or chemical drug products
  • Knowledge of drug development process and drug regulations
  • Experience in the area of analytical assay development would be an advantage
  • Good communication and interpersonal skills
  • Good writing and presentation skills
  • Able to analyse and integrate different sources of information to develop solutions
  • Able to work independently as well as in a team
  • Able to work effectively with people from other backgrounds, internal and external stakeholders
  • Highly motivated

Health Sciences Authority