Regulatory Affairs Specialist

2 days ago


Oslo, Oslo County, Norway TN Norway Full time
About the Job

We are looking for a highly skilled Regulatory Affairs Specialist to join our team in Oslo, Norway. The successful candidate will have a strong background in regulatory affairs and quality assurance, with experience in preparing and submitting regulatory documentation.

Responsibilities:

  • Assist in the preparation and submission of regulatory documentation.
  • Review and approve quality documents to ensure compliance with regulatory guidelines and requirements.
  • Conduct internal audits and participate in supplier assessments to maintain quality standards and regulatory compliance.
  • Support the maintenance and improvement of Quality Management Systems (QMS).
  • Ensure that all quality and regulatory documentation is accurate, complete, and in compliance with applicable regulations.

Requirements:

  • Degree in biotechnology, biology, chemistry, pharmacy, or a related field.
  • Experience in quality assurance and/or regulatory affairs, preferably within the life sciences or pharmaceutical sectors.
  • Familiarity with GMP, ISO standards, and other regulatory frameworks.
  • Strong analytical, problem-solving, and communication skills.


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