Senior Regulatory Compliance Specialist

hace 7 días


Alcobendas, Madrid, España Parexel A tiempo completo

About the Role

Parexel is seeking a highly motivated and detail-oriented Senior Regulatory Compliance Specialist to join our team. This role will be responsible for ensuring that Parexel stays up-to-date with regulatory updates and implements relevant requirements.

Key Responsibilities

  • Lead and coordinate all regulatory compliance activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
  • Act as the point person for regulatory consultancy services.
  • Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections.
  • Maintain the Regulatory Intelligence SharePoint and filing areas.
  • Provide technical knowledge where appropriate.
  • Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates.
  • Generate metrics on regulatory compliance activities.

Requirements

  • Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred).
  • Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
  • Good understanding of regulatory affairs landscape.
  • Project management capabilities applicable to regulatory compliance activities.
  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to rapidly learn, understand, and apply corporate procedures.

Salary Range

$80,000 - $120,000 per annum, depending on experience.



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