Country Approval Specialist - FSP - Nordics
RemoteSweden
Job Summary
Prepare, review, and coordinate local regulatory submissions (EU CTR) in alignment with global strategy under guidance. Provide local regulatory strategy advice to internal clients and manage project-specific SIA services and coordination. Serve as the key contact at the country level for ethical or regulatory submission activities, ensuring site start-up activities align with submission timelines and critical paths. Work with start-up CRAs to prepare regulatory compliance review packages and develop country-specific Patient Information Sheets. Maintain accurate trial status information on PPD tracking databases and ensure local study files are prepared per client SOPs. Achieve target cycle times for site activation while maintaining knowledge of regional regulatory guidelines and EC regulations.
Required Qualifications
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
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