
Regulatory Affairs Specialist
2 days ago
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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