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.
- 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
Responsibilities include:
- Serve as a primary 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
Technical and/or other job-related skills:
An understanding of China, US and EU regulatory requirements & expectations and criteria for submission & approval globally.
The background of regulatory CMC for supporting therapeutic biologic products and vaccines is preferred.
Demonstrated commitment & dedication to scientific & regulatory integrity & qualitycompliance.
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.
Sufficient level of knowledge in development & commercial activities and cGMP’s is required.
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, Documention, dossier workflow tools) and other data management tools
Qualifications (i.e., preferred education, experience, attributes)
Education:
· BS, MS or PhD degree in biotechnology, chemistry, 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:
Decision Making
· Acts Decisively
Risk Mgt
· Ability to recognize risks across projects and programs.
· Manages regulatory risks & ambiguous situations under direct supervision.
Scientific & Regulatory Leadership
· Ability to contribute to projects or team initiatives to support short-term operational goals.
· Ability to influence at the work group project team level.
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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs