YOUR TASKS AND RESPONSIBILITIES:• Liaise with Country Head of RA CH, regional RA APAC team and other stakeholders toa. Develop registration strategy and milestone plan for new drugs in line with local business priorities and export business.b. Manage the compilation and submission of applications for product registration and maintenance of licenses.c. Provide regulatory input in order to obtain timely regulatory approvals for the products by coordinating
YOUR TASKS AND RESPONSIBILITIES:• Liaise with Country Head of RA CH, regional RA APAC team and other stakeholders toa. Develop registration strategy and milestone plan for new drugs in line with local business priorities and export business.b. Manage the compilation and submission of applications for product registration and maintenance of licenses.c. Provide regulatory input in order to obtain timely regulatory approvals for the products by coordinating
Compile, review and submit pre-meeting packages for authority meetings conductrehearsal’s and participate in meetings as appropriate.• Handle Change Requests (CR), Non-conformities (NC) and CAPA cases within areaof responsibility.• Review of Device documentation, protocols and reports within area ofresponsibility. Assess the appropriateness of scientific/technical documentation forspecific regulatory purposes.• Responsible for archiving and retrieving
Compile, review and submit pre-meeting packages for authority meetings conductrehearsal’s and participate in meetings as appropriate.• Handle Change Requests (CR), Non-conformities (NC) and CAPA cases within areaof responsibility.• Review of Device documentation, protocols and reports within area ofresponsibility. Assess the appropriateness of scientific/technical documentation forspecific regulatory purposes.• Responsible for archiving and retrieving
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