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Malmo, Skåne, Sweden Capgemini Full time

We are seeking a highly skilled Regulatory Affairs Expert to join our team in Malmö. As a key member of our Compliance, Quality and Regulatory department, you will be responsible for ensuring our clients' pharmaceutical development meets stringent quality standards from initial research through to commercial manufacturing and product lifecycle management.

About the Role:

  • This is an opportunity to drive and support our clients in achieving their quality and regulatory objectives by delivering patient-focused, compliant, and efficient solutions.
  • You will collaborate with major pharmaceutical clients to navigate complex CMC regulatory requirements.
  • Your expertise will be crucial in preparing comprehensive technical documentation, specifically Common Technical Document (CTD) submissions.

Required Experience:

  • A degree within Biotechnology, Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical Engineering or closely related field.
  • Solid experience within regulatory affairs for the pharmaceutical industry.
  • A comprehensive understanding in Chemistry, Manufacturing, and Controls (CMC) within pharmaceutical development.
  • Knowledgeable in preparing comprehensive technical documentation.
  • A comprehensive understanding of EU pharmaceutical regulations, encompassing product registration, manufacturing processes, and compliance with EMA guidelines and GxP quality standards.
  • Fluent in spoken and written Swedish and English.

Additional Qualifications:

  • A comprehensive understanding of Certification of European Pharmacopoeia (CEP) standards and processes.
  • Knowledge of US pharmaceutical regulatory frameworks, including FDA guidelines and compliance requirements.