药品注册经理

该职位来源于猎聘 职责描述：

• Advise the Global Regulatory Team on regional considerations in developing strategy
• Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
• Plans and manages regulatory submissions (e.g. clinical trial and marketing applications) for products within client’s portfolio in compliance with global filing plans and local regulatory requirements.
• Have to have the experience in pre-sales for medical regulatory, will have to do up selling and cross selling for the existing business
• Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
• Leads development of regional regulatory documents and meetings in accordance with GRT strategy
• Provides regulatory direction on regional regulatory mechanisms to optimize product development
• Review regulatory dossier preparation and submission like new drug application, import license, site registration etc.
• Interacting with clients and follow up till final submission
• Identify and design training programs for team members
• To prepare team for Audit ready with updated regulatory guidelines, process and to prepare audit response report
• Conducting regular client calls for content-related discussions as well as for project status updates and delivery
• Expert in reviewing regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc....) and delivers to client
• Provided valued inputs for establishment, streamlining, and improvement of project processes
• Performing RCA when required with the team and preparing CAPA
• Work with internal stakeholders for project execution and actively participate in team meetings
• Ensure high standards of regulatory compliance as per client requirement.
• Maintain knowledge and understanding of SOPs, client SOPs/directives, and current regulatory guidelines 任职要求：
• Excellent knowledge of global regulations and hands-on experience in preparing and regulatory submission to China Health Authority (NMPA)
• 5-10 years of relevant experience
• Client facing ability with good communication skills
• Bachelor’s or Master’s in Life Science
• Bilingual skill (Chinese and English)