Regulatory Affairs Manager

4 weeks ago


Beijing, Beijing, China Pfizer Full time
Job Summary

Pfizer is seeking a highly skilled Regulatory Affairs Manager to join our team in China. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our CMC products, ensuring compliance with China regulations and guidelines.

Key Responsibilities
  • Develop and implement regulatory strategies for CMC products, ensuring compliance with China regulations and guidelines.
  • Collaborate with cross-functional teams to ensure effective and efficient regulatory submissions.
  • Manage and maintain CMC product information, market registration details, and component level dossier content.
  • Ensure timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems.
  • Prepare regulatory assessments and develop global regulatory strategies for projects across all aspects of drug development or manufacturing lifecycle.
  • Develop effective relationships with local and global internal partners, regulatory authorities, and pharmaceutical industrial associations.
Qualifications
  • BS, MS, or PhD degree in chemistry, biology, or related scientific disciplines.
  • 9+ years of experience in the pharmaceutical industry with relevant technical experience and 4+ years of pharmaceutical regulatory experience.
  • 2+ years of management and supervisory experience with technical projects and/or staff.
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.
  • 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.


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