Senior Quality & Regulatory Affairs R. Specialist

Muckelab

Portugal
Hybrid
Quality system performance
Compliance monitoring
Regulatory submissions
Muckelab is seeking a Senior Quality & Regulatory Affairs Specialist for their Animal Health division in Portugal. The role involves ensuring compliance with quality and regulatory standards, managing documentation, and supporting cross-functional teams in maintaining product integrity throughout its lifecycle

Job Summary

  • This position will be responsible for supporting Quality and Regulatory activities across incoming goods and distribution operations, ensuring compliance with applicable standards and requirements.
  • The role will contribute to Quality System performance, compliance monitoring, and key regulatory submissions and product maintenance activities.
  • Ensure timely preparation, submission, and follow-up of Marketing Authorization applications, and maintain authorized products through variations, renewals, and supplemental authorizations.

Matching Summary

Match Score: 85

Muckelab is seeking a Senior Quality & Regulatory Affairs Specialist for their Animal Health division in Portugal. The role involves ensuring compliance with quality and regulatory standards, managing documentation, and supporting cross-functional teams in maintaining product integrity throughout its lifecycle.

Skills & Requirements

Must-have

  • Quality System performance
  • compliance monitoring
  • regulatory submissions
  • Good Distribution Practices
  • EU regulatory requirements
  • Marketing Authorization applications

Nice-to-have

  • pioneered groundbreaking science
  • continuous innovation
  • work hand in hand with customers
  • empower those who care for animals

Key Requirements

  • Biological Sciences degree
  • Life Science background
  • Pharmaceutical Quality Assurance experience
  • Quality Assurance (QA) experience
  • Regulatory Compliance experience
  • Regulatory Submissions experience

Work Rights

Not specified

Tailored Resume

Cover Letter