Senior/ Regulatory Specialist (clinical), Therapeutic Products Branch
Singapore, Singapore
Job Description
What the role is
You will be part of a dynamic team that support clinical evaluation of therapeutic product registration submissions Work Location: Helios, 11 Biopolis Way, Singapore 138667 Responsibilities
- Critically assess the clinical dossier to determine the benefit and risk profile of therapeutic products within the targeted timeline and provide recommendation for regulatory decision of product applications
- To 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
- Possess knowledge and experience in related scientific disciplines, e.g., molecular biology, cell biology, immunology, or related disciplines
- Clinical research or medical practice experience
- Knowledge of clinical practice guidelines for different therapeutic areas
- 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
What you will be working on
What we are looking for
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Job Detail
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Job IdJD1270125
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned