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Job Summary: The Regulatory Associate is responsible for coordination, preparation of regulatory documents, and submission of meeting requests with China health authorities. The postholder may serve as the liaison for multi-functional teams that support clinical development across a range of therapeutic areas. Establish relationships with customers and be able to discuss regulatory issues. Maintain timelines and budgets for components of regulatory deliverables. In consultation with the line manager, responsible for organizing and managing project teams and for the quality and timeliness of assignments along with financial aspects. Provides advice and assistance to clients and internal stakeholders in areas of expertise. Ensures that the various project related tasks are completed in conformity with all Company policies, Standard Operating Procedures, and governmental regulations. . 1. Job Responsibilities: 1. Prepare and submit the consultation package to China health authority as well as the NDA projects in China, writing summary documents in dossier/organize and compile and archive the dossier 2. Project management for timely submission and delivery including financial aspects of projects to ensure high quality, on-time deliverables within the contracted budget 3. Prepare meeting minutes and follow-up with health authority. 4. Supports line-manager for business development, including prepare proposal to promising potential clients and generation of repeat business from existing clients and proposal development. 5. Perform regulatory intelligence, maintain and train on up-to-date regulatory requirements and guidance; conducts regulatory research on projects as needed. 6. Provides regulatory advice to clients and project team. 7. Arranges, and reports on client and regulatory agency meetings. 8. Assist Company regulatory promotional material and support Company booth in conference. 9. Maintains accountability for the quality of client deliverables. 10. Responsible for meeting personal utilization target and, where applicable, team or group targets. 11. Participates in Company community initiatives and demonstrates broader Company collaboration with the Regulatory Affairs business unit, as well as across the organization. 12. Defines, develops, and implements standards, procedures, and protocols and evaluates processes and services against those standards. 13. Prepares and maintains department budgets, with direction of line manager. Monitors utilization and expenditures to ensure staffing is appropriate for work required and that fiscal goals are met. 14. Prepares the organization for new or changing regulations. 15. Through publications and presentations, builds recognition of the Company’s expertise in the Regulatory Affairs and Product Development Strategy. 16. Performs other work-related duties as assigned. 17. Moderate travel may be required (up to 25%). Other Responsibilities: Performs other work-related duties as assigned. Qualification Requirements: ? BS degree, in a science-related field or equivalent experience in science/regulatory/medical writing-related field. ? Comprehensive regulatory knowledge and understanding of pharmaceutical/medical device product development. 3-5 years of experience in regulatory affairs within a CRO or sponsor organization, or in a closely related field. ? Demonstrated experience in contributing to the preparation of regulatory submissions including for example Pre-IND, IND, pre-NDA, NDA, CTA, MAA, and CTD, including electronic submissions. ? Excellent written and verbal communication skills. Good English reading and writing. ? Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently. ? Good project management, quality management and problem-solving skill. ? Computer literacy in MS Word, Excel, and PowerPoint. ? Good initiative, adaptability, and pro-activity. Good attention to detail, flexibility. ? Well-organized and logical thinking, and a great sense of responsibility