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Manager / 药学经理
2.5-3.5万
人 · 本科 · 5-7年工作经验 · 性别不限2024/11/13发布

五矿广场-B座

公司信息
辉瑞投资有限公司

外资(欧美)/5000-10000人

该公司所有职位
职位描述
Job Summary
* Collaborate with departmental and cross-functional colleagues (eg. GRS-CMC,
RA, Pharm Sci, 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.
* Delivery of high quality regulatory submissions.
* 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 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.
* Leverage both technical & regulatory knowledge, to mitigate risks.
* Execution of regulatory policies and operational processes.
* Actively contribute to cross-functional and strategic initiatives, novel
concepts and solutions to address gaps and mitigate risks and improve
conformance.
Job Responsibilities
* Serve as a primary China GRS-CMC representative on a core project(s) and
provide CMC support for products at various stages including clinical trial
application, NDA and post approval variations.
* 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
GRS-CMC systems, tracks regulatory commitments & timelines for specific
projects/products/markets with minimal supervision.
* Manage and Contribute to GRS-CMC 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
GRS-CMC Principles of Integrity.
* Develop effective relationships with local & global internal partners, e.g.
GRS-CMC, China RA, DC and PGS.
Technical Skill Requirements
* Sufficient level of knowledge in development & commercial activities and
cGMP’s is required.
* An understanding of China, US and EU regulatory requirements & expectations
and criteria for submission & approval globally.
* 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 desired.
* Demonstrated commitment & dedication to scientific & regulatory integrity &
quality compliance.
* Good 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
Qualifications
*
Education: BS, MS or PhD degree in chemistry, biology, or related scientific
disciplines; Advanced degree is preferred.
*
Experience: Technical discipline with 5+ years of experience in the
pharmaceutical industry with relevant technical experience (QA, Technical
Services, Operations, Manufacturing or R&D) and 2+ years pharmaceutical
regulatory experience are desired.
*
Desired / Required Competencies: Acts Decisively; Manages regulatory risks &
ambiguous situations under direct supervision; Ability to contribute to
projects orteam initiatives to supportshort-term operational goals; Ability to
contribute to effective teams & implement change; Approaching all situations
with enthusiasm and integrity despite demanding workload, technical barriers
and deadlines.

Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
#LI-PFE

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