Associate Registration Manager

I. Responsibilities  

• 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 Pfizer 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 China PBG 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 

II. Ensuring Regulatory Compliance 

• Ensure timely communicate  the requirement of CHP and other China regulations to PGS  QO and GCMC to facilitate the implement of CHP and other regulations in PGS sites 

• Ensure local process in place for the timely submission of all the quality and safety relevant variations including labeling safety update and  specification/manufacture process change  

III. Special Projects 

• Be required to participate on special projects for the Regulatory Sciences Group 

IV. Market Support  

• Attend Regulatory Sciences, Medical Department and other internal meetings as required.  

• Provide a resource for other sections of the company for specified therapeutic areas. 

V. Personal Development 

• Complete the Pfizer PRE Safety Reporting Process: Overview training module in the set timeframe. 

• Complete related Training.  

• Attend and actively participate in personal development courses as required.  

• Attend training in specific therapeutic areas as required.  

• Participate in Regulatory Sciences andMedical Department projects and workshops.