Global Regulatory Specialist

2 days ago


Oslo, Oslo County, Norway TN Norway Full time

About the Job

We are seeking a highly skilled Country Approval Specialist to join our team at TN Norway.

Key Responsibilities:

  1. Develop and implement local regulatory strategies in alignment with global submission plans.
  2. Prepare and coordinate regulatory submissions, including national applications and gene therapy approvals.
  3. Provide regulatory strategy advice to internal clients and maintain knowledge of relevant regulatory guidelines.
  4. Ensure compliance with company SOPs, client directives, and current regulations.
  5. Coordinate with internal departments to align site tasks with submission activities.
  6. Prepare regulatory compliance review packages and develop country-specific patient information sheets.
  7. Maintain accurate trial status information and ensure local study files are prepared and maintained according to SOPs.

Requirements:

  • At least 1 year of related experience or equivalent combination of education, training, and experience.
  • Effective oral and written 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 independently and as part of a team.
  • Good organizational and planning skills.

About Us

TN Norway is a leading provider of research and development services. Our mission is to empower our customers to make the world a healthier, cleaner, and safer place. We value diversity, integrity, intensity, innovation, and involvement.



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