上海招聘

Major Responsibilities and Duties:

1. Develop regulatory strategy and define regulatory execution plans in line with company’s strategy.
2. Ensure regulatory submission/approval in line with regulatory requirements.
3. Achieve successful submissions/approvals for responsible products.
4. Manage whole life cycle of products all regulatory submissions process including dossier preparation with high quality, timely responses to deficiency questions and efficiently resolve technical issues from registration test and cause inspection for all applications within planned timelines.
5. Work closely and swiftly with project team to update status of regulatory projects and share solutions for potential issues.
6. Intelligence: monitor and forecast regulatory environment and intelligence news periodically, and assess impact to company business, if any critical news, alert team timely.
7. Develop and coach direct reports by providing timely guidance on regulatory activities/necessary trainings and ensure deliverables of direct reports.
8. Lead discussion on critical regulation/guidance and provide regulatory policy related training to the company.
9. Lead the team to establish internal SOPs and maintain internal share disk, ensure all regulatory documentation archived in line with internal SOP.