R&D - GRA - Regulatory Affairs Manager -BJ

Be accountable for the regulatory strategy implementation by regulatory submission / approval for the assigned projects

•        Lead regulatory execution for the assigned products to ensure the successful submission/approval on time

•        Work with related functions at GRA and China region to implement the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy

•        Collaborate with related functiona at corporate, IA and work with affiliates to support the regulatory activities in the region

•        Ensure the high-quality submission with effective communication with agency and internal stakeholders/peers for the assigned projects/tasks

●      Be responsible to contribute and facilitate regulatory strategy for the responsible projects with the guidance of senior regulatory leaders

•        Work with related functions at global and China region to develop the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy

•        Work across project team and related workstreams to evaluate regulatory risk and identify the mitigation plan

•        Provide Regulatory strategy and professional support to cross-functions to ensure business success

•        Provide regulatory strategy and assessment/inputs to BD strategical projects and environment mapping

●      Be accountable for HA interaction for regulatory strategy assessment with the guidance of senior regulatory manager

•        Build up strong partnership with relevant government agency

•        Monitor and provide the professional assessment to the trend of regulatory policy, regulations and the new requirements and its implications

•        Collect regulatory intelligence and provide the analysis

●      Ensure regulatory compliance and work in compliance way

Education:

•        Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)

Experience & knowledge:

•        5years+ RA experience and 6 year’ industry experience is plus

•        Experience in handling complex regulatory submission including new product and marketed products, Bio product registration testing, and etc.

•        Good track record; *independent working; experience in drug/biologic manufacturing is a plus

Core competencies:

•        Good computer skill in EXCEL, POWERPOINT and WORD and AI tool;

•        Good interpersonal communication skill

•        Chinese and English (proficiency level) skill both in spoken and written

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