东莞招聘

Job Summary

Collaborate with departmental and cross-functional colleagues (eg. G-CMC, WSR, WRO, and PGS) to leverage and share both technical & regulatory knowledge, align expectations and manage planning and monitoring activities to mitigate risks, contribute to global regulatory strategies, deliver expeditious and efficient regulatory submissions for projects across all aspects of drug development or manufacturing lifecycle.

Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets.   

Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.

Possession of in-depth CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.

Continued pursuit of developing an understanding of regulatory conformance & compliance with external regulatory requirements & internal quality procedures.

Execution of regulatory policies and operational processes, mentoring others in specific areas of expertise

Actively contribute to cross-functional and strategic initiatives, novel concepts and solutions to address gaps and mitigate risks and improve conformance.

Job Responsibilities

Responsibilities include:

Take CMC lead to support products at various stages including clinical trial application, NDA and post approval variations

 Serve as a primary CMC contact on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.

Ensure high quality CMC submissions in compliance with China regulations and guidelines. Ensuring all regulatory activities for assigned products is executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.

Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.

Serve as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects. Mentoring colleagues may be expected within focus area of expertise.

Manage and Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.

Demonstrate ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.

Execute training related activities (e.g. compliance-related, HR policies…), individual development plans, participate in cross-disciplinary forums & learning opportunities, engage in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.

Develop effective relationships with local & global internal partners, e.g. GCMC, China RA, DC and PGS.

Develop relationships with regulatory authorities and network with pharmaceutical industrial associations to improve Pfizer’s regulatory success and enhance Pfizer’s image.

Technical Skill Requirements

Technical and/or other job-related skills:

Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is required.Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.

Strong understanding of CMC change management processes and CMC CTD content/structure.

Understanding of identifying and mitigating compliance risks through proper management of CMC product content

Sufficient level of knowledge and solid understanding of the development & commercial activities and cGMP’s required to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or project(s). Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.

Possesses sound understanding of business expectations across divisions

Ability to present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment, provide consultation as a scientific/technical resource for assigned projects, mentor and share experience with colleagues.

Deep understanding of China, US and EU regulatory requirements & expectations, criteria for submission & approval globally & experience of interactions with regulatory authorities for projects.Applies technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden & improve regulatory flexibility commensurate with business needs.

May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains

Demonstrates sound understanding and advanced knowledge of the principles, practices and concepts of a regulatory CMC/ policy/ publishing discipline and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.

May participate in Due Diligence exercises with supervision.

May participate in limited interactions with regulatory authorities to respond to direct requests either directly or in conjunction with Regulatory Affairs.

Advanced skills in written & oral communications in both Chinese and English are mandatory.

Computer literacy with Microsoft Office Suite and Documentum-based applications highly desired.Skills in document manipulation and electronic document maintenance (e.g., Word, Excel, Adobe, Documentum, dossier workflow tools) and other data management tools

Experience engaging in the external regulatory & pharmaceutical environment is preferred.

Prior experience managing projects is required.

Qualifications (i.e., preferred education, experience, attributes)

Education:

BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.

Experience: 

Technical discipline with 8+  years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 5+ years pharmaceutical regulatory experience are desired.

任职资格:

Desired / Required Competencies:

G-CMC Specific Responsibilities, Expectations & COMPETENCIES

Senior Manager

Decision Making

Acts Decisively

Applies experience & operates independently to resolve complex issues.

Impact of Decisions

Decisions impact multiple Sub Business Unit/Sub Operating Units mid-term objectives

Significant or long-term decisions are reviewed by senior management

Risk Mgt

Ability to recognize and address risks across projects and programs.

Manages regulatory risks & ambiguous situations under limited supervision.

Innovation/ Creativity

Investigates novel and unconventional approaches to address issues and solve problems.

Identifies existing process/product improvements

Develops innovative, advanced new concepts that improve processes / products across own and related disciplines

Takes appropriate risks to achieve desired results

Scientific & Regulatory Leadership

Ability to develop and/or lead projects or team initiatives to support short-term operational goals.

Ability to think globally across zones and divisions.

Ability to influence at the work group/discipline project team level.

Knowledge Breadth and Depth / Sharing

Provides technical / functional leadership to teams

Leverages technical/functional expertise across own and related disciplines.

Demonstrates comprehensive industry knowledge. Exhibits business expertise and an understanding of the external marketplace and customer requirements.

Actively shares knowledge with others across multiple Sub Business Unit/Sub Operating Unit through existing knowledge sharing processes/systems

Encourages others to share knowledge across the organization.

Teamwork/ Collaboration

Ability to contribute to effective teams & implement change.

Aptitude for customer service, facilitation, and conflict resolution, approaching all situations with enthusiasm and integrity, despite demanding workload, technical barriers and changing deadlines and requirements.

Communication

Communication & Negotiation skills

Uses communication to help ensure alignment within and outside of Sub Business Unit/Sub Operating Unit

Creates and delivers presentations to direct reports and other internal stakeholders across Sub Business Unit/Sub Operating Unit.

Demonstrates excellent verbal and written communication skills

Vision, Strategy, and Business Alignment

Establishes operational activities/projects that support mid-term goals and set direction for the Sub Business Unit/Sub Operating Unit.

Influencing Others

Manages teams that execute direction for the Sub Business Unit/Sub Operating Unit

Provides input to senior management decisions that may have an impact on business direction within the Sub Business Unit/Sub Operating Unit

Managing Change

Prepares for and manages change that impacts the Sub Business Unit/Sub Operating Unit.

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.