
Therapeutic Products Regulatory Coordinator
7 days ago
Job Summary:
We are seeking a skilled Clinical Affairs Coordinator to join our team. In this role, you will be responsible for managing applications and tracking key milestones for international collaboration projects on evaluation of drug applications.
Main Responsibilities:
- Screen Applications: Verify that required documentation for new drug applications and generic drug applications meet submission requirements for evaluation.
- Process Variation Applications: Process applications for post-approval changes to registered therapeutic products as part of product lifecycle management.
- Develop Procedures: Collaborate with the team to establish procedures for new services or enhance existing services related to therapeutic product registration.
- Case Management: Coordinate the submission, manage applications and track key milestones for international collaboration projects on evaluation of drug applications.
- Handle Procurement Matters: Work with Corporate Service teams on procurement matters.
- Develop Automation and Data Analytics: Develop automation and data analytic tools to analyse databases and generate insightful reports.
Requirements:
- Possess Knowledge in Pharmaceutical Science, Biomedical Science, Biotechnology or related disciplines.
- Prior experience with data analytics, automation and Python coding is an advantage.
- Prior work experience is not a requirement.
Benefits:
This role offers a competitive salary package, comprehensive benefits, and opportunities for professional growth and development.
Additional Information:
All text retained here is reformatted for clarity and structure without altering the original meaning.
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