Registration Manager Rcc

1 week geleden

Almere, Flevoland, Nederland Sandoz Voltijd

Major accountabilities:

  • As a specialist, responsible for regulatory affairs excellence and compliance activities in an assigned unit/ portfolio Actively participates in providing process excellence support to RA groups Key stakeholder and Point Of Contact(POC) for internal global audits as well as assigned external audits Actively provides support to assigned region/cluster/country with internal audit and external inspection preparation and CAPA proposals as needed.
  • Creates relevant remedial and improvement actions for Corrective Action Plans from Audits/Inspections Tracks, reports and followsup on completion and implementation of relevant tasks to ensure closure of audit observations.
  • Tracks and reports deviations/incidents in the appropriate systems together with RA groups Responsible for implementation of new processes, policies, metrics and appropriate training.
  • Ensures data compliance Partners with cluster/country Liaison group, to implement and track cluster/country related trainings related policies, processes and procedures.
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt Distribution of marketing samples (where applicable)

Key performance indicators:

  • Fully compliant portfolio with internal and external regulations and procedures Adherence to Novartis policy and guidelines Stakeholder/ project feedback

Minimum Requirements:

Work Experience:

  • Cross Cultural Experience.
  • Project Management.
  • Operations Management and Execution.
  • Collaborating across boundaries.

Skills:

  • Auditing.
  • Compliance Risk.
  • Data Analysis.
  • Operational Excellence.
  • Project Management.
  • Regulatory Compliance.
  • Regulatory Reporting.

Languages:

  • English.
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