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Associate Director, GRS CMC China

1 month ago

Beijing, Beijing, China Pfizer Full time
Job Summary

Pfizer is seeking an experienced Associate Director to lead the CMC Regulatory Affairs team in China. The successful candidate will be responsible for developing and implementing regulatory strategies to ensure compliance with China regulations and guidelines.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with China regulations and guidelines.
  • Lead the CMC Regulatory Affairs team in China, providing guidance and direction to team members.
  • Collaborate with cross-functional teams to ensure alignment and effective execution of regulatory strategies.
  • Manage regulatory submissions and ensure timely and accurate maintenance of CMC submission documentation.
  • Develop and maintain relationships with regulatory authorities and industry associations to stay up-to-date on regulatory requirements and expectations.
  • Provide technical and scientific expertise to support the development of global regulatory strategies.
  • Manage and prioritize workload to ensure effective execution of regulatory activities.
Requirements
  • 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.
  • Advanced skills in written and oral communications in both Chinese and English.
  • Computer literacy with Microsoft Office Suite and Documentum-based applications.
Preferred Qualifications
  • Experience engaging in the external regulatory and pharmaceutical environment.
  • Prior experience managing projects and independently executing the completion of complex projects.
About Pfizer

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