长沙招聘

Equal Employment Opportunity

5.MAJOR DUTIES:

*Thoroughly understand the regulatory policies, regulations and practices in China and expectations of multi-national companies in prosecuting regulatory submissions and strategies. Identify CMCregulatory requirements/expectations that are specific for China, and opportunities to leverage regulatory flexibility, where appropriate.

*Serve as a CMC expert in establishing regulatory strategies and a CMC liaison in preparing and supporting prospective submissions and subsequent regulatory query process (CTA, IND/NDA) in China. Directly support and liaise with Pharm Sci project teams before and during the CDE query response face-to-face meeting.

*Collaborate with all relevant GCMC functions (e.g., New Product CMC, Established Products CMC, GCMC BioTx, Regional CMC Hub - Asia Pacific) and PTx and BTx Pharmaceutical Science organizations to ensure cross functional collaboration with PGS, WSR and China PCO in optimizing the processes for supply of CMC information/documentation for China submissions.

*Serve as general consultant/facilitator to address China issues with focus on emerging CMC regulations including Ch.P.

*Lead or co-lead CMC China Network Policy Team and Internal Operations Team to prospectively engage in external advocacy activities to improve the Chinese regulatory system and to share timely China regulatory CMC knowledge and experiences with relevant Pfizer teams/functions.

*Contribute to the Asia Regional Regulatory Forum for developing best practices and sharing knowledge to facilitate internal alignment for regulatory submission.

*In collaboration with the Quality and Regulatory Policy group, QRP,

Assist in surveillance of existing and emerging Chinese regulatory environment and evolving policy issues globally (regulations, guidelines, policies, compendia, etc.) in support of GCMC, Quality and Regulatory Policy, PGS Compendial Affairs Group) and WSR.

Internally disseminate intelligence and share understanding of the impact on Pfizer's global operations and strategies for both pre- and post-approval expectations.

Support the provision of comments and feedback in development of regulation and guidelines in China.

*In collaboration with China PCO WSR, serve as a liaison with local China commercial teams to ensure alignment of Chinese commercial expectations with global commercial expectations and priorities.

*Seek opportunities to develop and maintain positive working relationship with the regulators at CFDA and other associated regulatory organizations via internal project consultation and via external engagements (e.g., symposium/workshop) to enhance understanding of drug development (e.g., quality by design) and advocate science and risk based regulatory flexibility.

*Network and form alliance with regulatory CMC professionals in pharmaceutical companies, professional and trade organizations (such as RDPAC, ISPE, DIA, PhRMA ) to lead and participate in engaging activities that can positively influence the regulatory environment in China.

INDIVIDUAL SPECIFICATION:

Essential AttributesPreferred Attributes

Education*Bachelor's degree or equivalent qualification in Chemistry, Pharmacy or related science/technical discipline

*Fluency in Chinese & English languages*Ph.D. or other graduate degree in a pharmaceutical technical discipline.

Experience & Technical Knowledge*Solid knowledge & grounded experience in Pharmaceutical industry

*Applied experience in developing & preparing regulatory submissions in China

*Capable negotiator w/Regulatory Authorities.

*Demonstrable collaborator & partner

*Familiarity w/ regional regulatory requirements in China & Asia Pacific and interpret these into business objectives.*Proven experience in managing regulatory compliance & conformance.

*10-15 years of experience in pharmaceutical industry and 3-5 years of experience in regulatory CMC

*Recognized leader in external regulatory &/or technical influence

Motivation*Self motivated in developing technical/regulatory leadership in China and the Asia-Pacific region.

*Focus on balancing business needs with regulatory expectations

*Driven to identify and innovative & effective opportunities to expedite regulatory approvals

*Respect for colleagues*Engaged externally with organizations, i.e., RDPAC

*Experience in external technical & regulatory collaborations

Personal

Character*Demonstrated leadership & ability to engage across disciplines & organizational levels

*Familiar w/Chinese culture & verbal & written fluency in Chinese & English

*Able to travel on business *Fluency in other languages

POSITION ACCOUNTABILITIES & EXPECTATIONS

Work DimensionsDescriptionRole Criteria

General DescriptionAutonomy: Exercises foresight & judgment in planning, organizing & guiding projects. Track record of successfully applying high level scientific judgment in a variety of situations.

Self Sufficiency: Works independently on assignments using knowledge & work experience. Gathers input from colleagues & management to address department objectives, critical issues & policy matters. Determines & pursues courses of action necessary to obtain desired results.*Demonstrated cross-functional GCMC leadership and accountable for developing regulatory CMC strategies for productS.

*Recognized China expert within GCMC.

*May represent GCMC during interactions with regulatory agencies and external partners (either directly or in conjunction with WSR).

*Serves as a key GCMC strategist for China.

*May contributes to pharmaceutical industry initiatives to influence development of external regulatory policies.

Technical ExpertiseLeading-edge knowledge of principles, concepts, & practices in a discipline, & knowledge of other relevant disciplines with increasing relevant experience.

Applies technical, functional, & industry knowledge to design & independently execute experiments/projects that shape the strategic direction of one or more projects. Provides scientific consultation at the function level.

*Demonstrated knowledge of current & emerging global regulations & guidelines & functional experience applying principles, concepts, & practices in a discipline & knowledge of principles, concepts, & practices of other relevant disciplines.

*Familiarity with fundamental business expectations across divisions.

*Fundamental knowledge and experience engaging in the external environment.

*Applies technical, functional, & industry knowledge to shape strategic direction for regulatory submissions in China. Independently able to execute completion of projects across multiple aspects of drug development or manufacturing lifecycle.

*Consults on several GCMC, WWPS/WRD, or PGS infrastructure & process projects.

*May act as GCMC lead in Due Diligence exercises.

*May participate in selection of external regulatory contract resources.

*Serves as a technical/country resource within function.

*Prepares regulatory strategy assessments.

*Identifies key issues for regulatory interactions & leads preparation of briefs.

*Leads interactions with regulatory agencies

Decision MakingAble to identify multi-disciplinary solutions & recommend a course of action to function level management.

Expected to troubleshoot in ambiguous situations across function. Limited level of uncertainty of successful outcome for some of solutions attempted.

Decisions impact the achievement of objectives.*Routinely looks beyond the obvious to identify multiple regulatory CMC solutions and recommends a course of action to project team and/or sub-function level management that have impact across divisions.

*Independently assesses regulations & guidelines for GCMC and function programs.

*Leads preparation of responses to draft internal policies & external guidelines.

*Decisions impact development within the function, influences the strategic approach of the product, and may have an impact on GCMC policy.

Innovation & CreativityWorks across function & across sites, to test & advance innovative processes, hypotheses, & methodologies; encourages curiosity & challenges the status quo in order to foster innovation.*Extends the applicability of precedent to regulatory approaches across function and sites, to stimulate and advance innovative processes, hypotheses, methodologies and strategies.

*Encourages curiosity and challenges the status quo in order to foster innovation.

*Lead teams to evaluate & improve GCMC processes, procedures and policies.

Teamwork & CollaborationInitiates & develops constructive relationships across sub-function & function to achieve the needs of the sub-function/function. May lead teams to help achieve departmental/project objectives.*Cultivates constructive relationships across function.

*Demonstrates ability to build effective coalitions.

*Serves as a primary representative or may lead cross-functional teams to achieve department/project objectives.

*Leads collaboration with other stakeholders (e.g., WRA, DSRD, SLS, PGS sites) to align global registration strategies.

*Serves as liaison (directly or in conjunction/WSR) with regulatory agencies for program activities.

*May represent GCMC on project governance bodies.

*Leads teams to achieve consensus for GCMC strategies.

*Significant collaboration within the GCMC line, as well as at other WWPS/WRD or PGS sites on projects and for GCMC initiatives.

*May collaborate with others external to Pfizer in scientific/regulatory disciplines.

*Leads document and information management teams.

Scientific & Regulatory LeadershipIdentifies & develops technical/regulatory strategies to support longer term goals & set direction and strategy for function level.

Influences at sub-function or function level. May lead multi-disciplinary teams.

Vision, Strategy & Business Alignment: Identifies & develops technical/regulatory strategies to support longer term goals & set direction & strategy for department or function level.*Leads development of China regulatory CMC strategies & anticipates regulatory outcomes in accordance with regulatory, scientific & technical criteria.

*Develops opportunities to expedite regulatory approvals to meet business needs.

*Leads global regulatory initiatives to develop policies, procedures and processes.

*Anticipates & manages the impact of team & work group activities on division goals.

*Develops global regulatory CMC/information management initiatives.

*Resolves regulatory CMC issues & conflicts with project/program stakeholders.

*Provides regulatory solutions at appropriate site governance boards/groups.

*Contributes to and/or leads limited duration teams at local or global levels.

*Expected to share experience, knowledge & regulatory intelligence across GCMC.

*Serves as a primary reviewer of CMC strategic plans & GCMC submissions.

*Recognized for regulatory knowledge & quality expertise as a Regulatory CMC Subject Matter Expert in one or more disciplines (e.g., L&E, QbD, Stability, etc).

*Demonstrates independent level of judgment initiating project activities, assessing regulatory risks & merits of development plans & developing regulatory strategies.

Supervision (where applicable)Experienced people manager.*Accomplish all mandated performance-related activities including goal discussions, mid-year and year-end performance reviews, development plan, compensation discussions.

*Provide constructive and positive feedback on a regular and frequent basis

*Provide guidance and facilitate opportunities for training and development

*Available for discussions

*Provide the tools, infrastructure and guidance needed for your staff to accomplish their objectives

*Balance the work load within your group and across groups (with the assistance of other Team Leaders)

*Encourage and support a healthy work/life balance

*Support the successful roll-out of established and new HR policies

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.