Regulatory Affairs Expert

7 days ago


Oslo, Oslo County, Norway TN Norway Full time

About the Role

We are seeking a talented individual to fill the position of Country Approval Specialist at TN Norway.

Key Responsibilities:

  1. Develop local regulatory strategies to support global submission plans.
  2. Prepare and submit regulatory documents, including national applications and gene therapy approvals.
  3. Collaborate with internal teams to align site tasks with submission activities.
  4. Ensure compliance with company policies, client requirements, and regulatory guidelines.
  5. Develop and maintain accurate trial status information and ensure local study files are prepared according to SOPs.

Requirements:

  • At least 1 year of experience in a related field or equivalent combination of education, training, and experience.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Ability to work independently and as part of a team.
  • Fluency in English and Norwegian.

About Us

TN Norway is committed to delivering high-quality research and development services. Our values include integrity, intensity, innovation, and involvement.



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