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 liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these.
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
post market scheduled regulatory compliance
Product License Maintenance Portfolio
electronic technologies for submissions
regulatory industry and local business environment
Nice-to-have
innovative thinking and meticulous attention
global/local teams
strong analytical and problem-solving skills
manage multiple projects and priorities
Key Requirements
2+ years of experience
applicable filing regulatory guidelines
Knowledge of drug development process
Familiarity with systems and electronic technologies