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.