Pfizer Registration Manager in Beijing, China

  • Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, where required.

  • Critically analyze data packages for regulatory compliance and identify discrepancies in data presented and request additional data.

  • Develop an overall perspective of registration projects.

  • Prepare responses to deficiency letters and ensure that these and other data requirements are submitted to regulatory agencies within the stipulated or agreed timeframes.

  • Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with the regulations and expedite approvals.

  • Maintain and update the Local Product Document (labeling) and Artwork in accordance with relevant regulations and PPG SOPs

  • Maintain an up to date knowledge of the relevant legislation in China.

  • Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.

  • Provide regulatory advice to company personnel as required.

  • Partner with the global regulatory and clinical development team in PEH/PIH BUs for new products development strategy and inline products strategy.

  • Partner with PGS and Pharma Sciences for the implementation China GMP, Chinese Pharmacopeia (CHP) and other China regulatory requirements in PGS sites.

  • Partner with PGS for supply strategy to avoid supply issue due to site changes

  • Provide regulatory inputs for the approval of promotional materials following applicable regulatory requirement, Pfizer policies, procedures, and practices

N: Not Applicable - 不适用 (China)

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