Product License Manager, Associate

pfizer.ca

Hybrid
Electronic and paper regulatory transactions
Post market scheduled regulatory compliance
Drug listing and establishment registrations
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
  • Drug listing and Establishment registrations
  • electronic technologies for submissions
  • relevant regulatory industry knowledge

Nice-to-have

  • continuous process improvement
  • global/local team participation
  • strong analytical skills
  • manage multiple projects simultaneously

Key Requirements

  • 2+ years of experience
  • applicable filing regulatory guidelines
  • Knowledge of drug development process
  • Proficiency in English

Work Rights

Not specified

Tailored Resume

Cover Letter