Associate Director, Regulatory Affairs and Compliance

4 days ago

Beijing, Beijing, China Pfizer Full time
Job Summary

We are seeking a highly skilled and experienced Associate Director to join our Regulatory Affairs and Compliance team at Pfizer. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC products, ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Lead the development and implementation of regulatory strategies for CMC products, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to leverage and share technical and regulatory knowledge, align expectations, and manage planning and monitoring activities to mitigate risks.
  • Deliver high-quality regulatory submissions, ensuring compliance with regulatory requirements and industry standards.
  • Maintain the expansive combination of CMC product information, market registration details, component-level dossier content, and compliance of an integrated regulatory change management process.
  • Assure product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Prepare regulatory assessments, develop and contribute to global regulatory strategies, and possess CMC regulatory knowledge and quality expertise.
  • Continued pursuit of developing an understanding of regulatory conformance and compliance with external regulatory requirements and internal quality procedures.
  • Leverage both technical and regulatory knowledge to mitigate risks and execute 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 resources and budget within GRS CMC China and track progress and metrics.
Qualifications
  • 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 of pharmaceutical regulatory experience is desired. 2+ years of management and supervisory experience with technical projects and/or staff is preferred.
Technical and/or Other Job-Related Skills
  • Demonstrated commitment and dedication to scientific and regulatory integrity and 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 and commercial activities and cGMP's required to assess technical, scientific, and regulatory merits of CMC information, commitments, and data to lead teams and/or projects.
  • 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 and expectations, criteria for submission and approval globally, and experience of interactions with regulatory authorities for projects.
  • Applies technical, functional, and industry knowledge to shape strategic direction of assigned projects, reduce regulatory burden, and 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 and 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 and pharmaceutical environment is preferred.
  • Prior experience managing projects is required. Able to independently execute the completion of complex projects to reduce regulatory burden and improve regulatory flexibility commensurate with business needs.

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