
Global Regulatory Specialist
2 days ago
About the Job
We are seeking a highly skilled Country Approval Specialist to join our team at TN Norway.
Key Responsibilities:
- Develop and implement local regulatory strategies in alignment with global submission plans.
- Prepare and coordinate regulatory submissions, including national applications and gene therapy approvals.
- Provide regulatory strategy advice to internal clients and maintain knowledge of relevant regulatory guidelines.
- Ensure compliance with company SOPs, client directives, and current regulations.
- Coordinate with internal departments to align site tasks with submission activities.
- Prepare regulatory compliance review packages and develop country-specific patient information sheets.
- 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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