To provide regulatory strategic and technical support to line manager for the purpose of extending Visirna business and building company assets by facilitating the submissions and approvals in a timely and high-quality manner.
1. Provide strategic and technical regulatory input and support to line manager to contribute for decision making on drug development strategy to deliver the highest value to business.
2. Independently compile high-quality submission document complying with external and internal requirement to provide right and clear drug profile and data to CDE to achieve targeted labeling and drug features to be approved.
3. Independently engage with internal and external stakeholders to follow up every milestone closely to ensure issue identified, escalated, resolved timely and target filing and approval timeline plan is achieved.
4. Establish and maintain a good relationship with key regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc. via professional communication.
5. Make sure line manager fully informed products registration status in daily work.
6. Support line manager on budget planning and monitoring in daily work.
7. Provide timely and high-quality regulatory support and input to internal key stakeholders such as medical, Nonclinical, CMC and commercial as needed.
8. Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.
9. Be sensitive to regulatory intelligence and willing to share.
