Senior Regulatory Compliance Specialist

hace 1 semana


Xico, México Novartis A tiempo completo

Estimated Salary: $120,000 - $180,000 per year.

We are seeking a highly skilled and experienced Senior Regulatory Compliance Specialist to join our team at Novartis in Ciudad de México. As a key member of our Quality department, you will play a critical role in ensuring compliance with Good Clinical Practices (GCP) and Pharmacovigilance regulations.

About the Role

We are looking for a talented individual with a strong background in GCP and PV auditing, who can lead independent audits, assess compliance with regulatory requirements, and identify areas for improvement. Your expertise will enable us to maintain high standards of quality and ensure patient safety.

Main Responsibilities

  • Lead, plan, conduct, document, and follow-up global quality regulatory compliance audits and assessments of GCP/GPvP according to NVS Quality Module and applicable regulations.
  • Assess the adequacy of responses to audit findings in agreement with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
  • Identify and communicate quality and regulatory compliance issues to Quality Management through appropriate channels.
  • Execute the risk-based Unified Quality Audit Plan (UQAP) and ensure accuracy of findings and completion of audits within established timelines.

Requirements

  • 7+ years of GCP/PV/Pharmaceutical Industry/Health Authority experience or equivalent.
  • 3 years of GCP/PV auditing experience; 5 years preferred; experienced in both GCP and PV auditing is ideal.
  • English fluency at operational and functional level (as first or second language; second language a plus).
  • Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.

Benefits

We offer a competitive salary range of $120,000 - $180,000 per year, commensurate with experience, as well as excellent benefits, including health insurance, retirement plans, and paid time off. Our dynamic work environment offers opportunities for growth and professional development.



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