R&D - Manager/Senior Manager, Regulatory Affairs -Beijing

R&D - Manager/Senior Manager, Regulatory Affairs -Beijing

Sanofi
5-6 years
Not Specified

Job Description


Job Description :
KEY ACCOUNTABILITIES:
  • Contribute and facilitate regulatory strategy for the responsible projects with the guidance of line manager
    • Work with related functions at GRA and China region to develop and implement the regulatory strategy of the responsible projects for the region, aligned with global strategy and regional business strategy
    • Regulatory supports for the related submissions in the region
    • Collaborate with related functiona at corporate, IA and work with affiliates to support the regulatory activities in the region
  • Be accountable for HA interaction for regulatory strategy assessment with the guidance of line manager
    • Work across project team and closely related workstreams to evaluate, Dossier gap assessment, Regulatory pathway and timelines, RA compliance, Implication of the findings on the deal terms, Ways to mitigate identified risks, implications on cost / time etc.
    • Align and formalize recommendations across RA organization (global, regional) and present the same in format as requested to integrate in the final internal documents (DD reports, management presentations, AIF etc.)
    • RA partner for BD on strategic projects and environment mapping
    • Update key changes in regulations and their implications
    • Inputs for strategic projects on RA regulations, requirements, trends
  • Be accountable for the regulatory strategy implementation by CTA / NDA submission / approval
  • Lead regulatory operations for the assigned products in China
    • Work with related functions in China to support business timely
    • Regulatory support to other fuctions
    • Ensure regulatory compliance and work in compliance way

JOB-HOLDER ENTRY REQUIREMENTS:
Education:
Bachelor degree or above in Pharmacy, Medical, Biology or related field
Experience & knowledge:
  • Experience in the global regulatory projects, knowledge for ICH, regulation in China, EU, US and Asia
  • Minimum 5-6 years RA experience and industry experience
  • Experience in handling complex regulatory submission including new product and marketed products
  • Good track record *independent working experience in drug/biologic manufacturing is a plus

Core competencies:
  • Good computer skill in EXCEL, POWERPOINT and WORD
  • Good interpersonal communication skill
  • Chinese and English (proficiency level) skill both in spoken and written

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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