
Senior/Regulatory Specialist
2 weeks ago
What the role is
[What the role is]
Quality Evaluation of Therapeutic Product
What you will be working on
[What you will be working on]
• Evaluate the Chemistry, Manufacturing and Controls (CMC) data of therapeutic product applications for regulatory approval 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 review
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
[What we are looking for]
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