Country Regulatory Specialist
2 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 be responsible for ensuring compliance with regulatory requirements and guidelines in the country of operation.
Key Responsibilities:- Prepare, review, and coordinate regulatory submissions with the Norwegian Medical Products Agency (RA), Ethics Committee (EC), and EU CTR part II submissions.
- Provide local regulatory strategy advice to internal clients and ensure alignment with global submission strategy.
- Have contact with investigators during the start-up period and coordinate with internal functional departments to ensure various site tasks are aligned with submissions activities.
- Prepare the regulatory compliance review (RCR) packages, as applicable, and develop country-specific Patient Information Sheet/Informed Consent form documents.
- Enter and maintain trial status information relating to start-up activities in systems/tracking databases in an accurate and timely manner.
- Maintain knowledge of and understand company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- More than 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 the ability to learn appropriate 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 committed to empowering our customers to make the world a healthier, cleaner, and safer place. Our team of over 100,000 colleagues shares a set of values: Integrity, Intensity, Innovation, and Involvement. Together, we expedite research and provide support to patients in need. If you are passionate about regulatory affairs and want to join a dynamic team, please apply by 16 August 2024.
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