Regulatory Compliance Specialist

4 days ago


Bengaluru, Karnataka, India Novo Nordisk Full time

At Novo Nordisk, we are committed to delivering high-quality products and services that make a difference in the lives of patients. Our Regulatory Compliance team plays a critical role in ensuring that our processes meet the highest standards of quality and regulatory compliance.

We are seeking a seasoned GCP Advisor to join our R&D Quality department. As a key member of our team, you will be responsible for facilitating knowledge sharing, ensuring compliance, and fostering a positive organizational culture in GCP.

About the Role:

  • Act as a quality anchor, reviewing and commenting on Clinical Deviation, Change Controls, and CRs.
  • Perform cross-functional data trending on quality signals and take on CAPA QA responsibilities.
  • Collaborate with global cross-functional teams to ensure seamless execution of quality processes.

Requirements:

  • Academic degree in medical, biological, or pharmaceutical science or similar.
  • Minimum 10-12 years of experience in GCP, with a deep understanding of relevant requirements impacting clinical trial conduct and Quality Management Systems (QMS).
  • Proficiency in clinical vendor assessment and comprehensive knowledge of GCP and drug development guidelines.

About Us:

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. We recognize the importance of unique skills and perspectives, and we work continuously to bring out the best in our people.



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