position title: sr. executive/associate manager, regulatory affairs

department:         regulatory affairs
report to:         manager of ra cmc
location:        beijing, china

position overview
support and/or take cmc lead for products under clinical development and for marketed drug products. coordinate various aspects of cmc regulatory activities with internal and external stakeholders. track & monitor china regulatory policy, perform assessment and cross-functional communications etc.

        provide cmc expertise to support drug development at various stages including clinical trial application, nda and post-approval variations
        lead and/or support communication with hq cmc and china ra team to ensure high quality cmc submissions n compliance with china regulations and guidelines
        act as a primary contact for cmc query response, lead and coordinate the response process between china and hq teams, and interact with the agency for project related cmc issues
        participate in china project development teams to identify cmc needs by working with regulatory and project leads
        work with regulatory colleagues on cmc technical topics, such as specification, drug registration testing and inspection for specific products
        track and monitory china cmc regulatory policy, coordinate to perform assessment, coordinate cmc policy discussion, communication and follow-up related activities
        maintaining cmc policy database and provide inputs on project registration strategic planning
        coordinate cmc team meeting

requirements
        bachelor or above in pharmacy, biology, chemistry or other related majors. advanced degree is preferred
        expertise in cmc areas such as chemistry, formulation, analytical, 2-5 years of r&d and/or regulatory experience
        knowledge in cmc regulatory requirements and ich guidelines
        good interpersonal communication skills and english skill (written & oral)
        proactive and team-work spirits, good coordination skill


if you are interested in this position, please send your resume to Dr. Li (e-mail:  lidan9617@126.com).

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