Senior Quality & Regulatory Affairs R. Specialist

Merck & Co., Inc., Rahway, NJ, USA

Portugal
Hybrid
Quality system performance monitoring
Good documentation practices
Eu regulatory requirements
Merck & Co., Inc. is seeking a Senior Quality & Regulatory Affairs Specialist for their Animal Health division in Portugal. This hybrid role involves ensuring compliance with quality and regulatory standards across operations, collaborating with cross-functional teams, and managing regulatory submissions

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.
  • For over 130 years, we have pioneered groundbreaking science and are driven by continuous innovation to develop breakthrough medicines, vaccines and technology.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Senior Quality & Regulatory Affairs Specialist for their Animal Health division in Portugal. This hybrid role involves ensuring compliance with quality and regulatory standards across operations, collaborating with cross-functional teams, and managing regulatory submissions.

Skills & Requirements

Must-have

  • Quality System performance monitoring
  • Good Documentation Practices
  • EU regulatory requirements
  • Marketing Authorization applications
  • labelling translations and artwork preparation

Nice-to-have

  • cross-functional team collaboration
  • external logistics partner management
  • continuous innovation and leadership

Key Requirements

  • Quality documentation review and approval
  • Quality System activities management
  • Good Distribution Practices execution
  • Marketing Authorization maintenance
  • Regulatory risk identification

Work Rights

Not specified

Tailored Resume

Cover Letter