Senior Quality & Regulatory Affairs R. Specialist

Merck Sharp & Dohme LLC

Rahway, NJ, USA
Hybrid
Quality documentation review and approval
Good documentation practices
Good distribution practices compliance
Merck Sharp & Dohme LLC is seeking a Senior Quality & Regulatory Affairs Specialist for their Animal Health division in Rahway, NJ. The role involves managing quality documentation, regulatory submissions, and compliance monitoring while collaborating with cross-functional teams to ensure product safety and reliability

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 Sharp & Dohme LLC is seeking a Senior Quality & Regulatory Affairs Specialist for their Animal Health division in Rahway, NJ. The role involves managing quality documentation, regulatory submissions, and compliance monitoring while collaborating with cross-functional teams to ensure product safety and reliability.

Skills & Requirements

Must-have

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

Nice-to-have

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

Key Requirements

  • Biological Sciences background
  • Life Science experience
  • Pharmaceutical Quality Assurance experience
  • Product Approvals experience
  • Product Lifecycle Management (PLM) Systems experience
  • Quality Assurance (QA) experience
  • Quality Management experience
  • Regulatory Compliance experience
  • Regulatory Risk experience
  • Regulatory Submissions experience
  • Technical Documentation Management experience

Work Rights

Not specified

Tailored Resume

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