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.
• Manage a team of colleagues within GRS CMC China, as well as resource and budget within GRS CMC China and track progress and metrics.

• Serve as a LT member within GRS CMC China and contribute to set and deliver the group objective.
• 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.
• Managing a small group of colleagues within GRS CMC China team, as well as resource and budget within GRS CMC China and track progress and metrics:
  • Conduct performance-management & training related activities, encourage & support a healthy work/life balance, support roll-out of HR policies, assist recruitment & hiring vacancies, provide guidance & facilitate opportunities for individual development, encourage colleague participation in cross-disciplinary forums & learning opportunities, engage colleagues in Straight Talk & Listen exchanges, demonstrate & model adherence to all Pfizer behaviors & values, embrace & comply with GCMC Principles of Integrity.
  • Providing guidance & direction for direct reports, managing resources & resource capacity along with prioritizing workload appropriately.
  • Ensuring all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
  • Fostering & actively developing GRS CMC China talent

• Education:
  • BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; Advanced degree is preferred.
• Experience:
  • Technical discipline with 9+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 4+ years pharmaceutical regulatory experience is desired.
  • 2+ years management & supervisory experience with technical projects and/or staff preferred.

• 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. Able to independently execute the completion of complex projects to reduce regulatory burden & improve regulatory flexibility commensurate with business needs.