Not specified; performance-based bonus mentioned; ...
Hybrid
Quality system for combination products
Design change management process
Regulatory submission documentation
This role serves as the liaison between the site and Worldwide Safety and Regulatory teams for combination product quality systems
Job Summary
This role serves as the liaison between the site and Worldwide Safety and Regulatory teams for combination product quality systems.
The specialist is responsible for performing design and regulatory impact assessments to determine necessary changes and preparing documentation for regulatory submissions.
Pfizer offers hybrid work arrangements, organized transport, and a comprehensive benefits package including free health check-ups and psychotherapy.
Matching Summary
This role serves as the liaison between the site and Worldwide Safety and Regulatory teams for combination product quality systems.
Salary
Not specified; Performance-based bonus mentioned; Holiday bonuses included
Skills & Requirements
Must-have
Quality System for Combination Products
Design Change Management Process
Regulatory submission documentation
PDM system usage
Market Impact Assessment
Nice-to-have
Problem solving skills
Analytical ability
Independent judgment
Collaborative team player
Meeting multiple deadlines
Key Requirements
University degree in pharmacy, biology, biotechnology, chemistry or related subject
More than 2 years of experience in pharmaceutical or device company