Regulatory Manager

pfizer.ca

Hybrid
Lead strategic regulatory activities
Obtain and maintain marketing authorizations
Support clinical trial applications
The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications in line with business goals and legal requirements

Job Summary

  • The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications in line with business goals and legal requirements.
  • Deliver Regulatory Strategy and Advise Cross-Functional Teams for assigned product and market responsibilities, develop and deliver optimal regulatory strategies to support local business and R&D goals for licensed and development products.
  • Pfizer is a patient-centric company guided by values of courage, joy, equity and excellence, aiming to create a trusting, flexible workplace culture that encourages work-life harmony and attracts talent.

Matching Summary

The Regulatory Manager will lead strategic regulatory activities for assigned products and markets to obtain and maintain Marketing Authorizations and support Clinical Trial Applications in line with business goals and legal requirements.

Skills & Requirements

Must-have

  • Lead strategic regulatory activities
  • Obtain and maintain Marketing Authorizations
  • Support Clinical Trial Applications
  • Deliver Regulatory Strategy
  • Advise Cross-Functional Teams
  • Manage New Registration Applications
  • Manage MA Variation Applications

Nice-to-have

  • Patient centric company
  • Digital transformation strategy
  • Flexible workplace culture
  • Diverse and inclusive workforce
  • Disability Confident Employer

Key Requirements

  • Expert knowledge of national legislation
  • Experience with EU MRP/ Decentralised MAAs
  • Experience with Centralized MAAs
  • Experience with MA Renewal Applications
  • Experience with Clinical Trials Support
  • Experience with Third Party Licenses
  • Experience with Devices regulatory activities

Work Rights

Not specified

Tailored Resume

Cover Letter