Mundipharma
Associate Regulatory Affairs Manager/RA manager
Beijing
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hirly's read of this role
- Seniority
- Lead / management
- Country
- CN
- Work mode
- On-site / unstated
- First seen by hirly
- 1 Sept 2026
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the posting
- 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.
Listed on hirly, a job board. hirly is not the employer: Mundipharma is hiring for this role.
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