北京市
职位亮点: 知名MNC,福利完善 职位描述: • Lead all regulatory affairs activities for VMRD China, build a high performing regulatory team and coach team members to enhance their personal development. • Ensure protocols/reports meet MARA/IVDC regulations, prepare and submit high quality dossier/supplementary documents to MARA/IVDC, coordinate and address queries raised by the regulatory authorities. • Work across teams (locally and globally) to define and execute robust regulatory strategies ultimately leading to the registration and commercialization of new products. • Engage Project Team members, and global VMRD experts to leverage global know-how and build on local regulatory expertise to deliver outcomes consistent with project plans. • Provide regulatory assessments and advice to all phases of biologics projects development, identify gaps and conduct gap analysis with project teams in a systematic manner to ensure swift progress of MARA regulatory reviews. • Ensure regulatory compliance in all aspects of the function. • Develop colleagues for succession plan. • Develop strong working relationships and act as a primary interface with the global VMRD organization and the local regulatory agencies. • As a Member of the VMRD China Leadership Team and part of the global regulatory network, provide input/insights to contribute to the agility, efficiency and outcomes of the Zoetis organization. 职位要求: • MS or Ph.D degree from relevant field with at least 10 years of professional experience in Biologic research & development. • Sound knowledge of the China regulatory requirements and legal framework for new technology, and Bio/Pharma veterinary medicinal products and of industry trends; self-motivated with demonstrated leadership skills; record of achievement in area of responsibility and demonstrated success in interactions with regulatory authorities. • Good communication, negotiation and organizational skills; strong team player; proficient in written/oral English communication; ability to efficiently work across lines. • Demonstrate innovative thinking and promote creative solutions across Teams.
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申请职位行业:制药 Pharmaceutical
职位类别:注册 RA
地区:北京市
职位类型:全职
01056011739