蚌埠招聘

工作职责:

JOB SUMMARY

The Associate Registration Manager assists with the regulatory maintenance of a portfolio of vaccine products. This includes the preparation of regulatory submissions to the Chinese authorities for registration of new products, variations to marketed products and clinical trial notifications, when required. The Associate Registration Manager will assist the line Managers on specific projects, and in some instances will be responsible for their own projects. The Associate Registration Manager ensures that each project operates within the set timeframes, is conducted to the highest standards of quality and is in accordance with local and international regulatory agency requirements and Pfizer Standard Operating Procedures. The Associate Registration Manager may also be required to assist on special projects for the Regulatory Affairs Group. Ensure optimal regulatory compliance in China.

JOB RESPONSIBILITIES

Indicate the primary responsibilities critical to the job.

Collaborate and Communicate with China PBG President on the ways to help the country meet annual objectives of different BUs and ensure regulatory supports to the marketing and sales effort through:

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 Pfizer 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 and clinical development team in China PBG BUs for new products development strategy and inline products strategy.

Partner with PGS and Pharma Sciences 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 communicate  the requirement of CHP and other China regulations to PGS  QO and GCMC to facilitate the implement of CHP and other regulations in PGS 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 the Regulatory Affairs Group

IV. Market Support

Attend Regulatory Affairs, Medical Department and other internal meetings as required.

Provide a resource for other sections of the company for specified therapeutic areas.

V. Personal Development

Complete the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe.

Complete related Training.

Attend and actively participate in personal development courses as required.

Attend training in specific therapeutic areas as required.

Participate in Regulatory Affairs and Medical Department projects and workshops.

任职资格:

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.

Certifications

Certificates of Educational background and related training certificates.

Education

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

Experience

At least 3 years experience in vaccine regulatory affairs working.

Technical

Strong Customer focus sense

Excellent communication & interpersonal skills

Excellent Teamwork/collaboration

Result orientated

Quality orientation

Excellent ability to research information

Able to work under pressure in a busy environment

Good working knowledge of international and local regulatory guidelines and codes

Good working knowledge of Microsoft Word, PowerPoint and Excel

Excellent English skill in speaking, reading and writing

Managerial

Cultural Competencies (Leader Behaviors)

Sustain Focus on Performance

Create an Inclusive Environment

Encourage Open Discussion and Debate

Manage Change

Develop People

Align Across Pfizer

ORGANIZATIONAL RELATIONSHIPS

Provide the primary groups or key role(s) that this role will have interaction with as a regular part of the Job responsibilities.  Include any external interactions as appropriate.

Collaborates with Midical, MI, CTM, Clinical Pharmacology, Clinical Development, Clinical Statistics, Safety etc.

RESOURCES MANAGED

Summary of resources managed.

May supervise contracted resources and external consultants on specific projects.

May have matrixed role on specific projects.

#LI-PFE

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手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承付的医疗卫生服务。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。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.