Pfizer PLS Manager in Shanghai, China
A Product License Support Manager will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.
Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.
Members of this team hold responsibility for verifying presence and consistency of required investigator related documents in the electronic Trial Master File facilitating the release of Pfizer sponsored investigational medicinal product. Additionally, following submittal of an initial IND, members of the team have accountability for compilation and submittal of IND Annual Reports. Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer's website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team. Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports. In addition, members of this team support submittal of advertising and promotional materials. Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in International markets.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.