Senior/ Regulatory Specialist - Buona Vista, Singapore - HSA Health Sciences Authority
Description
Quality Evaluation of Therapeutic Products- 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 review
Job Requirements
- Possess knowledge and experience in related scientific disciplines, e.g., molecular biology, biochemistry, chemistry. pharmacy or related disciplines
- Experienced in pharmaceutical manufacturing and quality control of biologics and/or chemcial drug products
- Experience in the area of analytical assay development would be an advantage.
- Knowledge of chemistry/molecular biology and manufacturing of pharmaceuticals / biologics
- Knowledge of drug development process and drug regulations
- Knowledge of international regulatory guidelines
- Good communication and interpersonal skills
- Able to work independently, as well as in a team
- Able to work effectively with people from different backgrounds
- Highly motivated with strong desire to protect public health and safety
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