Country Regulatory Affairs Specialist

1 month 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 approval of our products in the country.

Key Responsibilities:
  • Prepare, review, and coordinate regulatory submissions with the Norwegian Medical Products Agency (RA), Ethics Committee (EC), and EU CTR part II submissions.
  • Provide local regulatory strategy advice to internal clients and have contact with investigators during the start-up period.
  • Coordinate with internal functional departments to ensure alignment of submission process for sites and study.
  • Prepare regulatory compliance review (RCR) packages and develop country-specific Patient Information Sheet/Informed Consent form documents.
  • Enter and maintain trial status information in systems/tracking databases and ensure local country study files and filing processes are prepared and maintained.
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 the ability to learn appropriate 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 team of over 100,000 colleagues who share a set of values: Integrity, Intensity, Innovation, and Involvement. Together, we expedite research and provide support to patients in need. 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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