R&D - GRA - Regulatory Affairs Manager -BJ

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  • Beijing
  • Permanent
  • Full-time
  • 3 days ago
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 wayEducation:
  • 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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