Healthcare Regulatory Expert

2 days ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
Job Description

The Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs will be responsible for leading the Submissions & Compliance group and overseeing their development. The successful candidate will also develop and implement strategies for submission planning and performance improvement, collaborate with stakeholders, and maintain current knowledge of emerging regulations.

Key Requirements
  • University degree in Life Science - Good understanding of regulatory requirements and applicable legal frameworks
  • Minimum of 5 years experience in Global Regulatory Affairs in a similar role
  • Record of formal or informal leadership qualities
  • Extensive record of Variation management
  • Experience from artwork maintenance and associated label requirements
  • Experience from National procedure, DCP and MRP within the European Union
  • Strong working relationship/experience with regulatory authorities


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