蚌埠招聘

工作职责:

Role Summary:The position has overall regulatory responsibility for the development of new products in the portfolio and marketed products for IMBin China  in order to obtain timely approvals with competitive labeling,to ensure optimal regulatory compliance, and to optimize planning and execution of regulatory strategy for the entire productlife cycle. Responsible for building and maintaining excellent relationships with regulatory agencies to influence the regulatory system in China; proactively working with industry associations to plan and implement regulatory advocacy strategies Accountable for all direct contacts and interactions with national Regulatory Authorities through local RA representatives. Responsible for alignment of the Regulatory colleagues in China strategically and operationally to support the objectives of the China business. Responsible for creation and maintenance of a strong network through participation in and where appropriate leadership of local RA organizations and local industry associations.  Responsible for implementing GRA’s transparent one-voice policy and maintaining close alignment with other PFE stakeholders including commercial, medical development, regulatory operations, PGS, CMC, and safety.

Organizational Relationships:Reports to Head of GRA International

Resources Managed (budget and FTEs): The role manages a team of 40+ FTEs with people manager direct reports.

Responsibilities:

Development China

Serves as a key member of the extended Development China (DC) leadership team

Demonstrating extensive China regulatory knowledge & experience, balanced judgment, crisp decision-making and exemplary collaboration & business acumen

Product Registration

Responsible for regulatory strategy decisions on new Product Registration & in-line products maintenance for IMB as a basis for business decisions.

Ensures effective communication between the GRA global lines and teams and the China RA org, as well as between DC and the local RA organization.

Ensures the achievement of China business goals by implementation of timely and high-quality CTA and NDA/IDL submissions and by obtaining on-time marketing authorizations (including major variations and labeling changes).

Ensures timely RA supports to new business growth drivers

Ensures aligned communication across different BUs

Ensure development of strategies that leverage regional collaborations in Asia working with the GRA Internal – Asia group, DC, DJ, and other stakeholders

Enhancing Working Relationship with Health Authority

Exercising & enhancing engagements / relationships with regulatory authorities to improve Pfizer’s regulatory success and may serve externally as a representative to pharmaceutical trade group advisory committees. E.g. Member of RDPAC

Interfaces with NMPA/CDE/other relevant authorities to optimally position Pfizer as a key strategic partner in China.

Anticipates, communicates, and influences changes in regulations, guidelines, and policies that may affect the approval of new drugs or current marketed drugs in China, working with the global regulatory policy and intelligence group in GRA and other stakeholders.

Works with other stakeholders to ensure regulatory compliance in China according to local regulatory requirements and internal PFE standards.

Talent development and team construction 

Develops and maintains motivated and competent RA staff in China through participation in hiring, training, development and advancement. Instills and maintains a culture of innovation and transparency throughout the China RA organization.

Technical / Behavioral Competencies:Technical

Recognized expert with leading-edge knowledge of the drug development process and laws, regulations and practices affecting the pharmaceutical industry

Extensive relevant regulatory experience & business knowledge. Well connected to the external regulatory & pharmaceutical environment.

Strong management and project leadership skills, ability to provide advice and counsel to company staff for strategic decisions; routinely consulted as an internal expert on regulatory strategy. Serves as an external expert on regulatory policy.

Able to Influence and drive HQ decisions on China related projects.Demonstrates ability to apply regulatory knowledge to guide labeling recommendations and design as well as implementation of clinical development programs

Ability to organize/coordinate successful HA meetings/ manage complex relationships, working to effectively negotiate product approval and in-line product defense

Strong leadership - Creates & develops new strategic paradigms, directions & policies within the regulatory functions & division. Recognized as an outstanding regulatory leader & scientific/technical strategist across the division.

Good understanding of the international and Chinese regulations and guidance in order to design and implement robust strategies for new product registrations in China,

Excellent skills in communication, collaboration, negotiation and problem solving

Excellent English both spoken and written

Managerial

Sustain Focus on Performance

Encourage Open Discussion and Debate

Manage Change

Develop People

Align Across Pfizer

任职资格:

Qualifications (Training, Education & Prior Experience):Certifications

N/A

Education

A bachelor’s degree major in biology, chemistry, pharmaceutics, medical or a related life-science discipline, or equivalent. A master’s degree or above is preferable.

Experience

At least 15 years’ experience in multinational pharmaceutical companies including at least 6 years as a team leader. Registration experience across small molecules, biologicals, and vaccines preferable.

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.