Combination Product & Regulatory Compliance Specialist (m/f)

Pfizer

Savski Marof, Croatia
Not specified; yearly pyy increase + bonus based o...
Hybrid
Quality system for combination products
Design change management
Regulatory change management process
This role serves as the liaison between the site and Worldwide Safety and Regulatory teams to manage quality systems for combination products

Job Summary

  • This role serves as the liaison between the site and Worldwide Safety and Regulatory teams to manage quality systems for combination products.
  • The specialist is responsible for performing design and regulatory impact assessments 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 to manage quality systems for combination products.

Salary

Not specified; Yearly pay increase and bonus based on performance; Affordable meals, free fruit, hot beverages, and holiday bonuses included

Skills & Requirements

Must-have

  • Quality System for Combination Products
  • Design Change Management
  • Regulatory Change Management Process
  • PDM system usage
  • Product Change Form (PCF)
  • Market Impact Assessment

Nice-to-have

  • Collaborative team environment
  • Problem-solving skills
  • Analytical ability with scientific data
  • Independent judgment execution

Key Requirements

  • University degree in pharmacy, biology, biotechnology, chemistry or related subject
  • More than 2 years of experience in pharmaceutical or device company

Work Rights

Not specified

Tailored Resume

Cover Letter