Senior Quality & Regulatory Affairs R. Specialist

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

Portugal
Hybrid
Quality documentation review and approval
Good documentation practices compliance
Good distribution practices execution
Merck & Co., Inc. is seeking a Senior Quality & Regulatory Affairs Specialist to support Quality and Regulatory activities for its Animal Health division in Portugal. The role focuses on ensuring compliance with regulations, managing quality documentation, and collaborating with cross-functional teams to maintain product integrity

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, 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 to support Quality and Regulatory activities for its Animal Health division in Portugal. The role focuses on ensuring compliance with regulations, managing quality documentation, and collaborating with cross-functional teams to maintain product integrity.

Skills & Requirements

Must-have

  • Quality documentation review and approval
  • Good Documentation Practices compliance
  • Good Distribution Practices execution
  • EU regulatory requirements adherence
  • Marketing Authorization applications
  • Labeling translations and artwork preparation

Nice-to-have

  • Cross-functional team collaboration
  • Logistics partner management
  • Continuous innovation and leadership
  • Risk identification and mitigation

Key Requirements

  • Experience with Quality System activities (deviations, CAPA, change controls)
  • Experience with Marketing Authorization applications and maintenance
  • Experience with labeling translations and artwork preparation
  • Familiarity with Good Distribution Practices
  • Familiarity with EU regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter