|Job Title:||RA Head|
|Contact Name:||Cherry Zhu|
|Job Published:||January 20, 2020 14:39|
- Assist to develop and implement regulatory strategies.
- Provide regulatory advice and risk assessments on products to RA Team.
- Make regulatory plans and ensure fast registration approval, in line with regulatory requirements and China business objectives.
- Achieve successful submissions for pipeline products to regulatory authorities.
- Manage whole regulatory submissions process including dossier preparation with high quality, timely responses to deficiency questions and efficiently resolve technical issues from QC test for all applications within planned timelines.
- Work closely and swiftly with the functional department to update the status of regulatory projects and share solutions for potential issues.
- Provide competitors registration status to functional department.
- Intelligence: monitor and forecast regulatory environment and intelligence news periodically, and assess impact to company business, if any critical news, alert team timely.
- Lead team discussion on critical regulation/guidance.
Skills And Requirements
- Demonstrable experience in a similar role or capacity.
- University degree preferred.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.