Regulatory Affairs Expert
7 days ago
About the Role
We are seeking a talented individual to fill the position of Country Approval Specialist at TN Norway.
Key Responsibilities:
- Develop local regulatory strategies to support global submission plans.
- Prepare and submit regulatory documents, including national applications and gene therapy approvals.
- Collaborate with internal teams to align site tasks with submission activities.
- Ensure compliance with company policies, client requirements, and regulatory guidelines.
- 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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