以上为北京时间。链接检查不代表仍在招聘，申请前请以招聘官网为准。
按这个岗位的城市和方向提醒，确认后才开启，可选择每日或每周。
负责制定并执行中国大陆、港澳台地区的药品注册策略，主导IND、BLA、sBLA等申报工作，与药监部门高效沟通，确保项目按时高质量提交。要求10年以上药企注册经验，具备项目管理能力和中英文流利沟通能力。
This job role is responsible for working on cross-functional teams,developing and executing regulatory strategies, reviewing information and data,authoring submissions, and interacting with Health Authorities (the NMPA, etc.) to meet the aggressive urgent submission timelines for the assigned projects.
The individual will also contribute to regulatory process optimizations on relevant topics.
R&R:
l Manage the regulatory compliance of the whole life cycle.
l Responsible for developing and executing regulatory strategies, major focus on China Mainland,China Hongkong, China Macao and China Taiwan.
l Responsible for regulatory activities of the assigned products, focus on IND, BLA, and sBLA submissions, ongoing interactions/follow-up/supplemental submissions, with competitive timeline and high quality.
l Support R&D & clinical & medical with timely and precise regulatory assessment.
l Hands-on documentation drafting, reviewing and strategic supports experience for effective execution of the regulatory strategies and be responsible for the timely preparation and submission of regulatory application
l Interface with regulatory authorities as a primary contact person to liaise and negotiate effectively to ensure timely regulatory approvals.
l Cooperate with internal and external stakeholders to formulate project schedules, regularly communicate with cross functional, follow up project progress, discuss submission requirements, collect and prepare registration documents as required by healthy authorities, and ensure that projects are submitted as scheduled
l Other assignments.
Qualifcations:
l Bachelor degree or above in a life or pharmaceutical sciences or relevant scientific background.
l At least 10 years and above of relevant pharmaceutical industry experience, and prior regulatory affair and submission
related work experience such as IND, NDA, with understanding of GXP requirements and solid knowledge of ICH guidelines.
l Strong understanding of key regulations and submission requirements, and ability to apply to real case.
l Regulatory writing experience.
l Strong interpersonal, verbal communication, including fluency in English and Mandarin.
l Demonstration of RA project management skills including risk assessment, timeline and budget management and contingency planning.
Traits:
1. Build Partnership
2. Be Proactive
3. Demonstrate Integrity
4. Continuous Learning
5. Strive for Higher Quality
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