天津招聘

I. Responsibilities

• Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.
• Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.
•  Develop an overall perspective of registration projects.
• Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.
•  Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.
• Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and SOPs
• Maintain an up to date knowledge of the relevant legislation in China.
• Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
• Provide regulatory advice to company personnel as required.
• Partner with the global regulatory for new product development strategy and inline product strategy.
• Partner with PGS and Upjohn RDM for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.
• Partner with PGS for supply strategy to avoid supply issue due to site changes
•  Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices

  

II. Ensuring Regulatory Compliance

• Ensure timely communication of  the requirement of CHP and other China regulations to PGS  QO and Upjohn CMC to facilitate the implement of CHP and other regulations in manufacturing sites
• Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and  specification/manufacture process change

III. Special Projects

• Be required to participate on special projects for Regulatory Affairs

IV. Market Support

• Participate in Regulatory Affairs, Medical, Supply Chain, Commercial and other internal meetings as required.
• Provide a resource for other sections of the company for Upjohn product licences.

V. Personal Development

•  Complete related Training.
•  Attend and actively participate in personal development courses as required.

 

QUALIFICATIONS / SKILLS  

Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.

• Education 

Tertiary qualifications in pharmacy or a science degree with a pharmacology major.

• Experience

At least 6 years experience in regulatory affairs working.

• Technical

Excellent knowledge of local regulatory guidelines, Regulator organisation and product registration pathways

Proficiency in Basic Microsoft Word, PowerPoint and Excel

Ability Functional

Excellent communication in English  

Organizing and planning

Communication and interpersonal skill

Team spirit

Good sense in the area

Problem solving

Computer skill

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。