Senior/ Regulatory Specialist (quality Evaluation), Therapeutic Products Branch
Job Description
What the role is
What you will be working on
Work Location: Helios, 11 Biopolis Way, Singapore 138667
Responsibilities
• Evaluate the Chemistry, Manufacturing and Controls (CMC) data of product applications for drugs within the targeted timeline and provide a recommendation for the regulatory decision.
• Handle enquiries and requests from applicants, members of the public and industry stakeholders.
• Participate in projects and process/ regulatory review.
What we are looking for
Requirements
• Possess knowledge and experience in related scientific disciplines, e.g., molecular biology, biochemistry, pharmacy or related disciplines
• Experienced in pharmaceutical manufacturing and quality control of biologics
• Experience in the area of analytical chemistry would be an advantage.
• Knowledge of chemistry and manufacturing of pharmaceuticals
• 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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Job Detail
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Job IdJD1008787
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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