苏州招聘

Responsibilities
POSITION SUMMARY:
Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (i.e. Global vs. Country/Region) It may be helpful to complete this section after you have finished the other sections of the document.
The Consumer CMC Regional Team Leader will work closely with Pfizer Global Services (PGS), GCMC Regional Regulatory Conformance Hubs, Worldwide Safety & Regulatory (WSR), Regulatory Operations (WSRO) and Pfizer Country Offices (PCOs) to develop CMC strategies and provide input for risk mitigation (as needed). He / She will provide management of Consumer CMC personnel as well as regional or market specific oversight and strategic planning for authoring and delivery of CMC submission content to support new registrations and/or variations to Marketing Authorizations (eg Modules 2 and 3 of Common Technical Document (CTD)). He / She will assure effective communication and management of regulatory information and documentation for regulatory conformance and life cycle maintenance of Consumer products.

POSITION RESPONSIBILITIES:
In order of importance, list the primary responsibilities critical to the performance of the position. It is recommended not to list actual tasks but focus on essential responsibilities that highlight accountability and level of judgment required.
Core responsibilities include but are not limited to:
*Possess a high level of understanding of the technical/regulatory aspects and product characteristics that impact CMC regulatory strategy of assigned products
*Prepares / Authors accurate and complete CMC content to support:
oIntroduction of a new commercial product, including new market introductions for existing products
oPost-approval changes
oLicense maintenance (ex. Renewals, annual reports, gap closures)
*Ensures that submission related deliverables are provided in accordance with project timelines.
*Participates in the review and approval of newly authored submission content
*Performs functions within the RCCM (Regulatory Conformance Change Manager) process for changes impacting the specific global portfolio of products under his/her responsibility.
*Assists team or develops and communicates global/regional regulatory strategies (product & project-level) that identify regulatory risks & mitigation strategies and align with development and/or commercial plans
oBalancing regulatory requirements, constraints and risk posture with WSR, PGS, & Consumer Business goals
oLeverage diverse GCMC expertise and experience to share and incorporate learning's into future CMC strategies & submissions
oDevelop robust global CMC strategies and regulatory submission plans that provide fit for purpose regulatory submissions that will deliver market approvals
oCommunicate CMC strategies, regulatory risks and mitigation plans to PCOs in alignment with GCMC "One Voice" . Influence PCO/HA to adopt innovative CMC strategies, when needed
oUse in-depth knowledge of regional/country-specific pre- and post-approval CMC regulations to identify, interpret and apply local CMC requirements, in assigned region
oidentify country-specific/regional CMC requirements and opportunities to "bundle" changes to reduce PCO submission volume
oIdentify, assess impact & proactively communicate changes to local CMC regulations
oEnsure local submission plans and forecasts meet GCMC, WSR, & PGS requirements
*Interacts with PGS and the Regional Regulatory Hubs/PCOs/WRS/WSRO to ensure effective communication and management of regulatory information and documentation for regulatory conformance and Consumer product life cycle management.
*Identifies and escalates regulatory conformance issues to the appropriate leadership
*Provides regulatory support and assistance to technical groups within the region or market.
*Provides assistance to special projects requiring CMC input.
*Drives and leads discussions related to queries from Health Authorities, ensuring completeness of responses within requested timelines, and compliance of additional CMC information requests.
*Where necessary, provides assistance to internal compliance audits and assists in developing appropriate responses and action plans to address audit observations.
*Fosters a culture of strong performance, assuring that objectives and team goals are developed and measured in alignment with the mission and purpose of the overall organization, and with Pfizer's core values.
oLeads and participates in the recruitment, selection, promotion, termination and performance management of personnel and contract staff.
oLeads and provides direct input into the following activities:
oCoaching of direct reports
oDevelopment and oversight of training curricula and records
oIndividual development plans
oPerformance reviews
oSuccession planning
oEnsures training on and adherence to the appropriate SOPs, global business practices, policies and job aids, as consistent with business roles.
*Participates in Operational Excellence initiatives to identify and implement continous improvement strategies; tracks and reports progress. Assists in the determination and sharing of best practices across the organization.

Qualifications
EDUCATION AND EXPERIENCE:
Indicate the formal education, certification or license required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).
*Advanced degree (MS, PhD, Pharm. D.) with a minimum of 4 years of relevant experience, or Bachelors degree with a minimum of 6-8 years of relevant experience is required.
*Prior experience managing teams is preferred
*Managing cross-border relationships highly desired
*Prior experience managing projects is required
*Minimum of 4 years of relevant hands-on CMC experience (ex. authoring for initial or post-approval variations for marketed products) is mandatory
*Comprehensive understanding of CTD format and content is madatory
*Global regulatory experience with different Consumer submission types (drug, OTC, food, cosmetic, etc.) is highly preferred

TECHNICAL SKILLS REQUIREMENTS:
Indicate the technical skills required and/or preferred, as applicable.
*Experience working in the Pharmaceutical manufacturing industry (preferably QA, Technical Services, Operations, Manufacturing or R&D), knowledge of pharmaceutical development processes and cGMPs is required.
*Excellent English writing and oral presentation skills is mandatory.
*Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.

PHYSICAL POSITION REQUIREMENTS:
Note the physical conditions in which work will be performed, if applicable to the position. Examples: Lifting, sitting, standing, walking, ability to travel, drive, unusual attendance requirements, weekend work or travel requirements, etc.
*Some travel required

美国惠氏公司是财富全球500强企业之一，也是全球最大的以研发为基础的制药和保健品公司之一，总部位于美国新泽西州的麦迪逊市。惠氏是处方药、疫苗、生物制剂和非处方药发明、开发、制造和销售的领导者，也是研制营养品的先锋。惠氏在妇女保健、神经系统、肌肉骨骼系统、心血管系统的治疗、疫苗和抗感染、血友病、免疫制剂和抗肿瘤等领域都有领先产品。惠氏产品销售于140多个国家，改善了全球千百万人的生活质量。惠氏每年投入约20亿美元用于新产品的研究和开发，创新药物源源不断地推向市场。惠氏全球50,000多名员工，负有共同的使命，遵循一致的价值观， 正在为实现“成为一家得到员工、顾客和股东共同认可的世界上最好的制药公司”这一信念而努力。

惠氏中国投资项目：
惠氏于1986年进入中国市场，目前在中国批准注册的企业有四家，总投资超过3.8亿美元。现有在华员工2000多名， 在27个城市包括香港特别行政区在内都设立了办事机构，业务遍布全国。
 
惠氏制药有限公司介绍：
惠氏制药有限公司是美国惠氏在苏州投资的一家外商独资制药企业，于1991年在苏州市吴中区投资建厂，前期投资2990万美金，主要生产抗生素类药、妇女保健品、多种维生素及钙补充剂等处方类和非处方类药品。经过十多年的快速发展，惠氏制药苏州工厂取得了一系列的骄人业绩，成为惠氏在亚太地区的重要生产基地， 产品供应全国并出口亚太地区。

随着惠氏中国业务的高速增长和对未来中国经济和市场发展前景充分信心，美国惠氏总部将中国纳入“快速增长市场计划”，并决定进一步扩大苏州工厂的生产能力，加快新项目引进，于2007年新增投资5880万美金进行二期扩建项目，将于2010年竣工投产。未来的苏州工厂将成为一家拥有领先技术和设备，管理成熟的世界级制药公司。

公司重视和认可每一个员工的贡献和发展，为每一位优秀人才提供具有竞争力的薪资福利，培训体系，职业发展规划，人才晋升机制等各种机会，我们期待充满活力，有进取精神和责任心的优秀人才加入到我们的队伍中来，与我们共同分享机遇和挑战。

有意者请在截止期内将中英文简历（注明应聘职位、期望薪资）发送邮件至chinajob-suzhou@pfizer.com.