Country Regulatory Affairs Specialist

4 weeks ago


Oslo, Oslo County, Norway Thermo Fisher Scientific Full time
Country Approval Specialist

At Thermo Fisher Scientific, we are seeking a highly skilled Country Approval Specialist to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the successful execution of our global submission strategy.

Key Responsibilities:
  • Prepare, review, and coordinate regulatory submissions with various regulatory agencies, including the Norwegian Medical Products Agency and the EU CTR.
  • Provide local regulatory strategy advice to internal clients and ensure alignment with global submission strategy.
  • Coordinate with internal functional departments to ensure site tasks are aligned with submission activities and timelines.
  • Prepare regulatory compliance review packages and develop country-specific patient information sheets and informed consent forms.
  • Enter and maintain trial status information in systems and tracking databases.
  • Maintain knowledge of company SOPs, client SOPs, and current regulatory guidelines.
Requirements:
  • At least 1 year of related experience or equivalent combination of education, training, and experience.
  • Effective oral and written communication skills.
  • Excellent communication skills.
  • Strong attention to detail and quality of documentation.
  • Good digital literacy and ability to learn software.
  • Proficiency in English and Norwegian.
  • Ability to work in a team or independently, under direction, as required.
  • Good organizational and planning skills.

We are a company that values diversity, equity, and inclusion. We are committed to creating a workplace that is welcoming and inclusive for all employees. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.



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