仲望咨询致力于为企业提供中高级专业人才的招聘解决方案。迄今已有23年多历史，现在已经成长为亚洲领先的专业猎头顾问公司之一。
? Submit BLA Product applications to FDA as the contact person on behalf of Henlius, and manage all ongoing aspects of products regulatory activities in US including FDA interaction and notifications.
? Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs and supplements, annual reports, safety reports, etc. Maintain all ongoing applications in US including submission of license renewals, annual reports, and annual fee to maintain compliance with FDA regulations.
? Support and manage preparation of meeting requests and briefing documents.
? With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
? Support US RA head, assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
? Plan and execute regulatory deliverables, such as regulatory sheets and labeling reviews, involving cross-functional team members. Participate on project teams and provide expertise on regulatory matters.
? Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
? Coordinate work with external partners in US including ownership of work instructions; work collaboratively with partners to coordinate sampling, inspection and testing of products imported into US and ensure all regulatory activities fully compliance with US regulation.
? Monitor US FDA Regulations and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.