北京招聘

?Serving as CMC representative on a core project(s), managing project activities, assessing regulatory risks & development plans to develop Chinese regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

?Managing regulatory issues, maintaining submission information in relevant CMC systems, tracking regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

?Presenting and articulating issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.

?Authoring and/or coordinating CMC activities for new registrations, post approval changes, line extensions, authorized generic filings and all license maintenance activities.  Coordinating & contributing to responses to Agency queries and performing quality review of regulatory CMC submissions.

?Serving as a technical and scientific resource and providing guidance for completion of difficult and complex projects.

?Prioritizing & independently completing assigned workload appropriately.

?Developing effective relationships with local & global internal partners, i.e., R&D, UGS, Country Regulatory Leads, other CMC lines.

?Developing relationships with regulatory authorities to improve Pfizer’s regulatory success.

?Executing training related activities (e.g. compliance-related, HR policies) & individual development plans, participating in cross-disciplinary forums & learning opportunities, engaging in Straight Talk & Listen exchanges, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.

?Managing and contributing to CMC-related projects, initiatives & actions.

?Participating, as required, in pharmaceutical industry conferences or serving externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.

?Mentoring colleagues within focused area of expertise.

Education and Experience:

 

?Bachelor’s degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline with 6+  years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.

?Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.

?Advanced skills in written & oral communications (Chinese and English) are mandatory.

?Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

?Prior experience managing projects is preferred.

 

Technical and/or other job-related skills:

 

?Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP’s required to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or project(s).

?Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.

?An understanding of regulatory requirements & expectations, criteria for submission & approval locally (China) and regionally, and experience of interactions with regulatory authorities for projects.

?Updates, interprets, and applies local CMC guidelines.  Ability to contribute to local/regional regulatory strategies by proactively discussing with partners.

?May participate in limited interactions with regulatory authorities to respond to requests either directly or in conjunction with Regulatory Affairs personnel.

?Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

?Experience engaging in the external regulatory & pharmaceutical environment is preferred.

?Emerging awareness of new scientific or manufacturing technology.

?Possesses sound understanding of business expectations across divisions

?May serve as Subject Matter Expert in specific relevant disciplines or as a recognized resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

?Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.

在辉瑞，我们致力于运用科学以及我们的全球资源来改善每个生命阶段的健康状况。在药品的探索、开发和生产过程中，我们致力于设定品质、安全和价值标准。我们多样化的全球医药产品包括生物药品、小分子药品和疫苗，以及许多世界驰名的消费产品。每天，世界各地的辉瑞员工致力于寻找我们这个时代最为棘手的疾病的预防和治疗方案。辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可负担的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。

为了践行上述诺言，辉瑞创建了新的业务机构-辉瑞Upjohn. 辉瑞Upjohn 兼具创业公司的敏捷性、以及全球财富百强企业的资源和能力。因此，我们在创新与快速执行方面拥有独特的优势，包括激活我们的研发产品线、提高生产效能，以及快速推进产品研发等方面。

在辉瑞 Upjohn，我们相信，建立审慎的合作伙伴关系和开展协同合作，对创建可持续的医疗卫生解决方案至关重要。我们热切希望成为非传染性疾病(NCD)防治领域的***合作伙伴。由于中国市场与日俱增的重要性和机遇，同时为了确保我们能有效制定正对当地需求的健康解决方案 - 辉瑞 Upjohn高层管理团队的一些重要成员(每位都有20多年行业经验)和大部分部门都将在中国工作。这将使辉瑞 Upjohn真正实现本地化，并具备必要的速度和灵活性，从而在保持同辉瑞相关组织强有力联系的同时，切实抓住各种增长机遇。