Associate Regulatory Affairs Manager/RA manager

About the role

- 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.

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Company Intel

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