Apply with hirly
Associate Regulatory Affairs Manager/RA manager
Mundipharma · Beijing
Upload your resume to see how well you match this job — free, in seconds, no account needed.
Your resume is used only to score it against this job. If you don't create an account, it is deleted within 24 hours.
- Develop and implement registration plan for new products in China within relevant therapeu-tic areas.
- Manage registration submissions for new products registration and clinical trial applications.
- Manage registration submissions for license renewal and variations of marketed products and ensure optimal regulatory support to product lifecycle management for business objectives.
- Ensure successful implementation of Regulatory Affairs and high quality of filing dossier.
- Establish and maintain direct contact with European / regional regulatory team for information sharing and ensuring timely support.
- Undertake interactions and negotiations with Regulatory Authorities to optimize regulatory approvals.
- Closely follow up regulation changes and analyze/predict its impact on company registration strategies.
- Keep RA Head informed for the progress of regulatory projects, identify and discuss critical issues and potential solutions before implementation.
- 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.