Country Regulatory Affairs Specialist
4 weeks ago
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 execution of our global submission strategy.
Key Responsibilities:- Prepare, review, and coordinate regulatory submissions with various regulatory agencies, including the Norwegian Medical Products Agency and the EU CTR.
- Provide local regulatory strategy advice to internal clients and ensure alignment with global submission strategy.
- Coordinate with internal functional departments to ensure site tasks are aligned with submission activities and timelines.
- Prepare regulatory compliance review packages and develop country-specific patient information sheets and informed consent forms.
- Enter and maintain trial status information in systems and tracking databases.
- Maintain knowledge of company SOPs, client SOPs, and current regulatory guidelines.
- 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 ability to learn 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 company that values diversity, equity, and inclusion. We are committed to creating a workplace that is welcoming and inclusive for all employees. 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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