Your role will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations
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 participates on global/local teams to complete assignments and tasks within a specific task force/project.
Matching Summary
Your role will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.
Skills & Requirements
Must-have
electronic and paper regulatory transactions
Drug Listings and Establishment Registrations
Product License Maintenance Portfolio
electronic technologies for submissions
applicable filing regulatory guidelines
Nice-to-have
pharmaceutical organizational structures
strong analytical and problem-solving skills
manage multiple projects simultaneously
global regulatory submissions and requirements
Key Requirements
2+ years of experience
Knowledge of drug development process
Familiarity with submission systems and technologies