The Product License Manager, Associate role at Pfizer involves ensuring compliance with regulatory obligations related to drug listings and establishment registrations. The position requires attention to detail, understanding of regulatory guidelines, and the ability to manage multiple projects in a hybrid work environment
Job Summary
Your role will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.
Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
Contributes to the completion of moderately complex projects and liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these.
Matching Summary
Match Score: 85
The Product License Manager, Associate role at Pfizer involves ensuring compliance with regulatory obligations related to drug listings and establishment registrations. The position requires attention to detail, understanding of regulatory guidelines, and the ability to manage multiple projects in a hybrid work environment.
Skills & Requirements
Must-have
electronic and paper regulatory transactions
Drug Listings and Establishment Registrations
post market scheduled regulatory compliance
electronic technologies for submissions
regulatory industry and local business environment
Nice-to-have
innovative thinking and meticulous attention
strong analytical and problem-solving skills
ability to work independently and as part of a team
manage multiple projects and priorities simultaneously
Key Requirements
2+ years of experience
understanding of applicable filing regulatory guidelines
knowledge of drug development process
familiarity with systems and electronic technologies