Regulatory Affairs Specialist
About this role
Job title: Regulatory Affairs Specialist
Job Purpose The responsibility of the Regulatory Affairs Specialist is to support customers’ requests regarding referencing of Datwyler Drug Master Files for drug approvals, facilitate washing validations, ensure provision of standards, etc.
Main Tasks & Responsibilities
- Responsible to assess customers requests for LOA to reference Drug Master Files (DMFs)
- Issue LOA drafts for US-FDA, Health Canada and NMPA China.
- Maintain LOA data base, prepare analysis and share with the sales teams as required
- Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs
- Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats.
- Arrange samples and testing data required for submission
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