Manager, CMC / ????Test123

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 support short-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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.