職位描述
1. Develop and implement registration plan for new products in China within relevant therapeutic areas.
2.Manage registration submissions for new products registration and clinical trial applications.
3.Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
4. Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.
5. Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support.
6. Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.
7.Closely follow up regulation changes and analyze/predict its impact on company registration strategies.
8. Keep RA Head informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.
9. Contribute to company systems development, support China RA team to develop or enhance regulatory related SOPs, management systems, working procedures, etc. to improve team operational efficiency.
任職要求：
1. Profound knowledge of pharmaceutical business, worldwide drug development and regulatory processes, expertise of international and national regulatory guidelines.
2.Ability to effectively manage interactions with internal and external stakeholders for ensuring optimal cooperation.
3.Understanding of market access needs and implementation of appropriate measures for health care purposes.
4. Strong interpersonal skills and ability to interface effectively with company local relevant functions and global regulatory team.
5. Ability to anticipate and facilitate issue resolution to meet local registration requirements.
6.High leadership skills with both practical and short/long term strategic vision; ability to build relationships; strong team leader as well as team player.
7.Demonstrates and encourages ownership and responsibility; drive/motivation - has a “can-do” attitude and is committed to delivering high quality results and strives for continuous improvement.
8. A good blend of strategic and analytical thinking; innovative personality; able to see the bigger picture.
